FDA Adverse Event
Injury
Summary report: N
EXOFINFUSION PREMIERPRO MESH
MDR report key: 16590320
·
Received March 21, 2023
Report
- Report Number
- MW5115902
- Event Type
- Injury
- Date Received
- March 21, 2023
- Date of Event
- March 13, 2023
- Report Date
- March 20, 2023
- Manufacturer
- SVS LLC.
- Product Code
- MPN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PATIENT HAD EXOFIN APPLIED TO HER SURGICAL SCAR AND IT CAUSE LOCAL CELLULITIS AND SKIN BREAKDOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24453 | EXOFINFUSION PREMIERPRO MESH | TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN | MPN | SVS LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Other |