Complaints & Vigilance
Post-Market Surveillance Protocol

Two separate channels

Commercial questions and product quality issues follow different paths. This page covers the quality path, which exists so that a product problem reaches the manufacturer and, where required, the competent authorities without delay.

• Commercial matters — orders, quotations, payment, shipping, short shipment, damage in transit. Contact our sales team at [email protected] or see our After-sales & Returns Policy.
• Product quality, complaints and suspected adverse events — use the channel described below.

Where to report

Send quality complaints and suspected adverse events to [email protected] . This inbox is monitored and routed to the responsible quality contact. If you prefer, you may also contact us through the contact form and mark the inquiry as a quality complaint.

What to include

A complete report lets us act and lets the manufacturer assess the issue without a round trip. Please provide, as far as you have it:

• the product name and the batch number printed on the unit or carton;
• your purchase reference — invoice or order number, and approximate date of receipt;
• the quantity concerned and how many units are affected;
• a clear description of what was observed, with photographs or a short video;
• for temperature-controlled products, the recorded transport and storage conditions;
• for a suspected adverse event, the approximate date and setting of use and a description of the outcome, in de-identified form.

Do not send patient-identifying information. A de-identified summary — age band, presenting indication, what was observed, timing — is sufficient for our assessment and for onward reporting. Retaining the original clinical record is your responsibility as the treating or distributing party.

Please retain the complaint sample and the packaging in a controlled condition until we confirm whether it is needed, so that batch and sterility findings can be preserved.

What happens next

1. Acknowledgement. We confirm receipt and assign the report a reference.
2. Triage. We assess whether the report describes a product quality issue, a suspected adverse event, or both.
3. Escalation to the manufacturer. Product complaints are transmitted to the manufacturer with the batch and reference details so that the batch history and any related reports can be examined.
4. Regulatory reporting. Where the applicable medical device vigilance or adverse event framework requires reporting, the manufacturer and, where it holds the obligation, the in-market responsible party report to the competent authority within the prescribed timeline. We cooperate with that process and provide the information we hold.
5. Outcome. We communicate the conclusion and, where corrective action affects the supplied goods, we contact the affected records directly.

Reporting timelines and roles

The deadlines for reporting to a regulator depend on the market, the parties involved and the seriousness of the event. Reporting timelines are typically short — in many frameworks measured in days, and in some cases in 24 to 48 hours for the most serious events.

Because of this, please report to us as soon as you become aware of a suspected quality issue or adverse event, rather than waiting for a full investigation. Early notice preserves the ability of the parties who hold reporting duties to meet them.

In most markets the duty to report within a jurisdiction rests on the manufacturer, the importer, the authorised representative or the distributor established there. Where your company holds that role in your market, you remain responsible for meeting your own jurisdiction's reporting requirements; our role is to supply the manufacturer-side information and to coordinate promptly. Discuss the allocation with us at the start of a supply relationship so it is clear before an event occurs.

Recalls and field safety corrective actions

If a batch supplied to you becomes subject to a market withdrawal, field safety corrective action or recall, we notify you in writing with the batch details and the action required. We ask you to identify and quarantine affected stock, trace onward distribution where you have made one, and confirm the action taken so that it can be reported as complete.

Confidentiality

Complaint information is handled for the purpose of investigating and reporting the issue. We share it with the manufacturer and, where reporting is required, with the competent authority, and otherwise keep it confidential in line with our Privacy Policy.

Contact

Quality complaints and adverse events: [email protected]
General inquiries: [email protected]
Shandong Plurvel Medical Technology Co.,Ltd, Qufu, Shandong, China