Complaint Form

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Complaints about medical devices require regulatory reporting when they involve events that may have caused or contributed to a death or serious injury, or when a device malfunctions in a way that could lead to death or serious injury if it were to recur. Manufacturers must report such events to the FDA within 30 calendar days of becoming aware of them. In cases where the event poses an unreasonable risk of substantial harm, reports must be submitted within 5 work days.

Complaints are prioritized based on the severity of the issue, with urgent cases involving safety concerns addressed immediately.

The outcomes of a complaint investigation can vary depending on the findings. Here are some common outcomes:

1. Corrective Actions: If a problem is identified, steps are taken to correct it, such as repairing or replacing the defective device.
2. Preventive Measures: Actions are implemented to prevent the issue from recurring, which may include changes to manufacturing processes or product design.
3. Regulatory Reporting: If the complaint involves a serious issue, it may be reported to regulatory authorities like the FDA.
4. Customer Communication: The complainant is informed of the investigation results and any actions taken to resolve the issue.
5. Product Recall: In severe cases, a product recall may be initiated to address widespread issues.
6. Process Improvement: Insights from the investigation are used to improve overall product quality and safety.