MAUDE Adverse Event Report: CHEMENCE MEDICAL INC. EXOFIN HIGH VISCOSITY TOPICAL SKIN ADHESIVE

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

Patient Problem Wound Dehiscence (1154)

Event Date 06/27/2023

Event Type  Injury  

Manufacturer Narrative

No product reference code or lot code was provided, as such, a formal investigation could not be performed.This type of complaint will be monitored and trended to determine if corrective action is necessary.

Event Description

The patient experienced wound dehiscence noted at the surgical site with skin irritation around the incision.

• Brand Name: EXOFIN HIGH VISCOSITY TOPICAL SKIN ADHESIVE
• Type of Device: TOPICAL SKIN ADHESIVE
• 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: 18003017
• MDR Text Key: 326474758
• Report Number: 3010034760-2023-00006
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other