Medical Device Complaint Form

Report a Medical Device Complaint

As a licensed medical-device supplier, Sterile Mate LLC maintains a formal complaint-intake process required under 21 CFR Part 803 (FDA MDR). Use this form to report any adverse event, malfunction, or quality concern involving a device we supplied. Reports involving death or serious injury are prioritized within one business day.

Emergency? Do not use this form. Call 911 for medical emergencies. For device-related urgent recalls, call our compliance line at 800.988.3892.

1. Reporter Information

Who is filing this report

Full name *

Role / title

Organization / facility

Email *

Phone

Mailing address

2. Device Information

Identify the device involved

Device name / description *

Manufacturer

Model number

Lot / serial number

UDI (if known)

Purchase / delivery date

3. Event Details

What happened, when, and where

Date of event *

Location (facility / department)

Full description of complaint or event *

4. Patient Outcome (MDR Classification)

Required for FDA reporting classification

A patient was involved in this event

Event contributed to or caused a death Event caused a serious injury Device malfunctioned but no patient harm

Other outcome or context

5. Follow-up & Corrective Action

The device is available for return / inspection

Corrective action requested

Additional evidence you can provide

Submissions are logged under 21 CFR Part 803. Sterile Mate reviews every report; if the event involves death or serious injury, a compliance officer will contact you within one business day.