Medical Device Complaint Form

Medical Device Complaint Form — Form Fields

This healthcare template includes 7 fields. Allows patients, caregivers, or staff to report issues, malfunctions, or adverse events related to medical devices. Supports regulatory compliance and post-market surveillance obligations. Free to customize and use on ZenBuild.

• Reporter Name (text, required)
• Email Address (email, required)
• Device Name and Model (text, required)
• Type of complaint (dropdown selection, required) — options: Device malfunction or failure, Patient injury or adverse event, Packaging or labeling issue, Sterility concern, Performance not as expected, Other
• Did the event result in patient harm? (multiple choice, required) — options: Yes, No, Potential for harm, but no injury occurred
• Please describe the complaint in detail (long text, required)
• Attach supporting documentation (photos, reports, etc.) (file upload, optional)