FDA Adverse Event
Malfunction
Summary report: N
MICROMATRIX
MDR report key: 20247740
·
Received September 17, 2024
Report
- Report Number
- MW5159693
- Event Type
- Malfunction
- Date Received
- September 17, 2024
- Date of Event
- September 5, 2024
- Report Date
- September 13, 2024
- Manufacturer
- ACELL, INC.
- Product Code
- KGN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A 62 YEAR OLD FEMALE CAME INTO SCI OUTPATIENT WOUND CLINIC FOR MICROMATRIX APPLICATION AND A VAC CHANGE WITH PLASTIC SURGERY. MICROMATRIX PRODUCT WAS OPENED AND THE SURGEON NOTED A CONTAMINANT PRESENT IN THE MATERIAL. THE MATERIAL WAS SET ASIDE AND NEVER TOUCHED THE PATIENT (NO HARM CAME TO THIS PATIENT). TWO NEW PACKAGES WERE OPENED, BOTH WERE FINE AND USED ON THE PATIENT WITHOUT INCIDENT. MICROMATRIX (MANUFACTURER IS ACELL); LOT NUMBER: 040297 AND SERIAL NUMBER: (B)(6) WAS USED. RID TAG SCANNED IS: (B)(4). IMPLANT GROUP MADE AWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2295348 | MICROMATRIX | WOUND DRESSING WITH ANIMAL-DERIVED MATERIAL(S) | KGN | ACELL, INC. | 040297 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |