MAUDE Adverse Event Report: CHEMENCE MEDICAL EXOFIN FUSION; CUTANEOUS TISSUE ADHESIVE WITH MESH

Model Number	EF70401
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Several attempts were made to obtain more information about the complaint and no additional information was received.A review of the production records was performed and no anomalies were noted.A trend analysis was performed and complaints of this type remain low and stable.Chemence will continue to monitor this and other complaints to determine if further action is needed.
Event or Problem Description
The user reported that three patients experienced skin reactions after application of exofin fusion.

• Brand Name: EXOFIN FUSION
• Common Device Name: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): CHEMENCE MEDICAL; 200 technology drive; alpharetta GA 30005
• MDR Report Key: 11148299
• Report Number: 3010034760-2021-00001
• Device Sequence Number: 3607731
• Product Code: OMD
• UDI-Device Identifier: 00818566019851
• UDI-Public: 0100818566019851100069F217
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K191461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 01/14/2021
• Device Model Number: EF70401
• Device Lot Number: 0069-F2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1