MAUDE Adverse Event Report: PREMIER PRO / SVS LLC. PREMIERPRO EXOFINFUSION 22CM MESH; TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN

Model Number 3472

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Rash (2033)

Event Date 02/20/2023

Event Type  Injury  

Event Description

Rash surrounding surgical incision following use of exofin product.

• Brand Name: PREMIERPRO EXOFINFUSION 22CM MESH
• Type of Device: TISSUE ADHESIVE FOR THE TOPICAL APPROXIMATION OF SKIN
• Manufacturer (Section D): PREMIER PRO / SVS LLC.; 13034 ballantyne corporate pl; charlotte NC 28277
• MDR Report Key: 16453996
• MDR Text Key: 310550353
• Report Number: MW5115284
• 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: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3472
• Device Catalogue Number: 3472
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White