MAUDE Adverse Event Report: CHEMENCE MEDICAL PRODUCTS INC. EXOFIN FUSION 22CM; CUTANEOUS TISSUE ADHEISVE WITH MESH

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

Patient Problems Wound Dehiscence (1154); Reaction (2414)

Event Type  malfunction  

Event Description

Per physician reports, 10 pts have developed complications believed to be related to use of exofin fusion 22cm (glue and mesh product).One pt - septic total knee requiring irrigation and debridement; 1 pt - dehisced wound, sutures placed in physician office; 2 pts - the product fell off exposing the incision days before first post op appt.Two pts developed blisters under the mesh.Three pts developed allergic type reactions to product.Therapy start date: (b)(6) 2018; therapy end date: (b)(6) 2018.Reason for use: closure of surgical incisions.

• Brand Name: EXOFIN FUSION 22CM
• Type of Device: CUTANEOUS TISSUE ADHEISVE WITH MESH
• Manufacturer (Section D): CHEMENCE MEDICAL PRODUCTS INC.
• MDR Report Key: 7813094
• MDR Text Key: 118392912
• Report Number: MW5079369
• Device Sequence Number: 0
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other