MAUDE Adverse Event Report: CHEMENCE MEDICAL INC. EXOFIN FUSION; TOPICAL SKIN ADHESIVE WITH ADJUNCT WOUND CLOSURE DEVICE

Model Number	3472
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No lot number was provided at the time of the reported complaint.Follow-up correspondence was sent for this information.Pictures were not provided but requested.A trend analysis was performed and this event type remains low and stable.This event type will continue to be trended to determine if additional action is necessary.
Event or Problem Description
During the post-op follow-up in the clinic, two weeks after surgery, exofin fusion peeled off in less than a week.The patient had to be seen in the urgent care for wound care.

• Brand Name: EXOFIN FUSION
• Common Device Name: TOPICAL SKIN ADHESIVE WITH ADJUNCT WOUND CLOSURE DEVICE
• Manufacturer (Section D): CHEMENCE MEDICAL INC.; 200 technology dr.; alpharetta GA 30005
• Manufacturer Contact: charnelle thomas ; 1121 alderman dr.; alpharetta, GA 30005 ; 6786890760
• MDR Report Key: 18906108
• Report Number: 3010034760-2024-00004
• Device Sequence Number: 7887441
• Product Code: OMD
• UDI-Device Identifier: 00818566019851
• UDI-Public: 00818566019851
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

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
• Device Model Number: 3472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown