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