PRODUCT SAFETY, ADVERSE EVENT REPORTING & RECALL POLICY

1. Why This Policy Exists

G 1 Healthcare (Pty) Ltd holds SAHPRA Medical Device Establishment Licence No. 00005410MD, authorising it to distribute and import Class B medical devices in South Africa. That licence carries continuing obligations: we must monitor how the devices we supply perform in the field, investigate problems, report reportable events to the South African Health Products Regulatory Authority ("SAHPRA") within fixed deadlines, and be able to remove a defective batch from the market.

This policy tells you how to report a problem, what we do with your report, and what will happen if a product you have received is recalled. It is published in terms of the Medicines and Related Substances Act 101 of 1965 and the Regulations Relating to Medical Devices and In Vitro Diagnostic Medical Devices (Government Notice R.1515, Government Gazette 40480 of 9 December 2016), and follows SAHPRA guideline SAHPGL-MD-03 on medical device vigilance.

2. What Counts as an Adverse Event

SAHPRA defines an adverse event as a failure of a medical device, a difficulty in using it, or an undesirable outcome associated with its use, that results in — or is likely to result in if it recurs — death, serious injury or a serious deterioration in the state of health of a patient, a user or another person.

For the products we supply, please report any of the following:

• a pouch, barrier, flange or coupling that leaked, detached, split or failed to adhere;
• a filter, tap or drainage valve that did not work as intended;
• a skin reaction, burn, blistering, ulceration or peristomal skin breakdown you associate with the device;
• an allergic or sensitisation reaction to an adhesive, barrier or component;
• packaging that arrived open, damaged, wet or with a broken sterile or tamper-evident seal;
• a product that was past its expiry date on arrival;
• anything in the labelling or instructions for use that is wrong, missing, unclear or misleading;
• a device that appears counterfeit, tampered with, or not what was ordered; and
• a near adverse event — a failure that caused no harm this time, but could have, or could if it happened again.

If you are unsure whether something is reportable, report it. Over-reporting costs you an email. Under-reporting can cost somebody their health.

3. How to Report

Email support@g1healthcare.co.za with ADVERSE EVENT in the subject line, or message us on WhatsApp at +27 84 498 6840, or use our contact form. Please include as much of the following as you have:

• your name and contact details, and whether you are the patient, a carer, or a healthcare professional;
• the product name and SKU, and the order number if you bought it from us;
• the lot or batch number and expiry date printed on the packaging — this is the single most useful item, because it lets us identify every other unit from the same batch;
• the date the event happened and what happened, in your own words;
• the outcome, including any medical treatment sought; and
• photographs of the device and the packaging, if you can take them safely.

Please keep the device and its packaging. Do not discard it, wash it or return it to a pharmacy. We may ask you to send it to us for examination, at our cost, and may need to forward it to the original manufacturer. Where retrieval is not possible we will tell you how to dispose of it safely.

You may also report directly to SAHPRA. Reporting to us does not remove your right to do so, and healthcare professionals are encouraged to do both.

4. What We Do With Your Report

• Acknowledge. We acknowledge every safety report within one business day and open a vigilance record.
• Triage. Our Authorised Representative assesses whether the event is associated with the device and whether it meets SAHPRA's reporting criteria, using the decision tree in SAHPGL-MD-03. Where there is doubt about reportability, we report.
• Trace. We use the lot, batch and serial records we are required to hold to identify every other unit from the affected batch and everyone who received one.
• Report. Reportable events are submitted to SAHPRA on the Medical Device Adverse Event Reporting Form (GLF-MD-11A), signed by our Authorised Representative, within the deadlines in clause 5.
• Escalate to the manufacturer. We forward the report to the original manufacturer for assessment under its own post-market surveillance system, and submit the manufacturer's findings to SAHPRA.
• Act. Depending on the finding, we may correct labelling or instructions, issue a field safety notice, quarantine remaining stock, or recall the batch.
• Close the loop. We tell you the outcome of the investigation and what has been done.

Where an exemption from reporting applies under SAHPRA's exemption rules, we document the reasons for not reporting and retain that record for inspection. An exemption never applies where SAHPRA has flagged the device or issue for close monitoring, or where we detect a change in the frequency or pattern of an event.

5. Our Reporting Deadlines to SAHPRA

These deadlines run from the moment we become aware of the event — which, in most cases, is the moment your report reaches us. Please report promptly. An initial report is submitted within the deadline even if the investigation is incomplete, followed by supplementary reports and a final report.

Adverse events occurring outside South Africa in relation to a device we also supply here are recorded and kept available for SAHPRA on request, as the guideline requires.

6. Recalls and Field Safety Corrective Actions

A field safety corrective action is any step taken to reduce a risk of death or serious deterioration in health associated with a device already on the market. It may involve a recall, a withdrawal, a quarantine of remaining stock, a labelling correction, or advice on modified use.

6.1 How we will contact you. If you received an affected lot, we will contact you directly using the details on your order — email first, then telephone or WhatsApp if we do not hear back. We will also publish a recall notice on this website. Business and institutional customers receive a field safety notice addressed to their named contact.

6.2 What we will ask you to do. Stop using the affected product immediately, isolate any remaining units so nobody else uses them, and follow the instructions in the notice. Never continue to use a recalled device because it "seems fine".

6.3 What it costs you. Nothing. Recalled product is replaced or refunded in full at our expense, including return carriage. A recall is not a return under our Returns & Refunds Policy and no return condition, time limit or hygiene restriction applies to it.

6.4 Stopping supply. Where a recall is instituted we cease further sale of the affected device and do not resume it until SAHPRA has approved resumption in writing, or we withdraw the device from supply in South Africa.

6.5 Why we need your correct contact details. A recall only works if we can reach you. Please keep the email address and telephone number on your account current. This is also why we retain distribution records even after you close an account — see clause 13 of our Privacy Policy.

7. Traceability Records We Keep

For every unit dispatched we record the product and SKU, the lot or batch number, the serial number where the device carries one, the manufacture and expiry dates, the order it belonged to, and the person or institution that received it. This is a regulatory requirement, not a commercial choice, and it is what makes a targeted recall possible instead of a blanket public warning.

These records are handled as confidential health-related information. See clause 5 of our Privacy Policy.

8. Counterfeit and Diverted Product

Devices bought from unauthorised resellers, marketplaces or informal traders cannot be traced through our records and may be counterfeit, expired, or stored outside the conditions the manufacturer specifies. We cannot vouch for their safety, we cannot include them in a recall, and the warranties in our Terms and Conditions do not extend to them.

If you suspect you have been supplied a counterfeit G1 Healthcare product, tell us — we will investigate and report it to SAHPRA. We will still accept and investigate an adverse event report about a device we did not supply, because patient safety comes before provenance.

9. Complaints That Are Not Safety Events

A late delivery, an incorrect item, a damaged carton with an intact product, or a billing error is a service complaint rather than an adverse event. Raise those through our contact page or your account support screen, and see clause 19 of our Terms and Conditions for escalation to the Consumer Goods and Services Ombud. If a service complaint turns out to have a safety dimension, we treat it as an adverse event from that point on.

10. Your Rights Are Not Affected

Nothing in this policy limits your rights under the Consumer Protection Act 68 of 2008, including the implied warranty of quality in section 56 and the liability of producers, importers, distributors and retailers for harm caused by unsafe goods, a product defect or inadequate instructions under section 61. Reporting an adverse event to us is not a waiver of any claim.

11. Contact

G 1 Healthcare (Pty) Ltd — Registration No. 2025/451756/07

SAHPRA Medical Device Establishment Licence No. 00005410MD (Class B, valid to 3 March 2031)

Registered Office: 3 Inglenook Road, Riverside Lifestyle Estate, House 14, Nahoon Valley Park, Eastern Cape, 5202, South Africa

Adverse events and safety: support@g1healthcare.co.za (subject line: ADVERSE EVENT)

WhatsApp: +27 84 498 6840

SAHPRA: www.sahpra.org.za