MAUDE Adverse Event Report: SVS LLC. EXOFINFUSION PREMIERPRO MESH; TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN

Catalog Number 3472

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Skin Inflammation/ Irritation (4545)

Event Date 03/13/2023

Event Type  Injury  

Event Description

Patient had exofin applied to her surgical scar and it cause local cellulitis and skin breakdown.

• Brand Name: EXOFINFUSION PREMIERPRO MESH
• Type of Device: TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN
• Manufacturer (Section D): SVS LLC.
• MDR Report Key: 16590320
• MDR Text Key: 311841392
• Report Number: MW5115902
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 3472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American