MAUDE Adverse Event Report: CHEMENCE MEDICAL INC EXOFIN MICRO SM; TOPICAL SKIN ADHESIVE

Model Number	M1206
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Burning Sensation (4540); Contact Dermatitis (4546)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no additional information obtained at the time of this report.We will continue to monitor and trend this event type to determine if action is needed.
Event or Problem Description
The complainant reported that multiple surgeons have noted that exofin takes significantly longer to polymerize compared to dermabond.They have also noticed an increase in patient complaints of itching, burning, and local irritation at incision sites, along with several suspected allergic type reactions necessitating office and ed visits.

• Brand Name: EXOFIN MICRO SM
• Common Device Name: TOPICAL SKIN ADHESIVE
• Manufacturer (Section D): CHEMENCE MEDICAL INC; 200 technology drive; alpharetta GA 30005
• Manufacturer Contact: jamica brown ; 1121 alderman dr; alpharetta, GA 30005 ; 6786890760
• MDR Report Key: 24861905
• Report Number: 3010034760-2026-00006
• Device Sequence Number: 9367638
• Product Code: MPN
• UDI-Device Identifier: 40854137001151
• UDI-Public: 0140854137001151
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: M1206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2026
• 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