MAUDE Adverse Event Report: CHEMENCE MEDICAL EXOFIN MASTIC

Model Number	EM80148
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abrasion (1689)
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report mw5188831 received indicating: "employee professional staff nurse, expert - iv therapy, on (5/19) notified clinician iv therapy that she experienced a medical device-related injury while seeing a patient.When preparing iv supplies, rn opened and applied pressure to the applicator on a exofin mastic liquid adhesive vial.67ml, unspsc (b)(4), upmc item #(b)(4).The inner portion of the vial is a glass ampul that is meant to break and release fluid to the sponge applicator.The glass broke through the plastic applicator and cut rn's finger.No concerns of bbp exposure.On the package insert, it does state to "crush vial before opening this package." no patient involvement occurred during this injury.".

• Brand Name: EXOFIN MASTIC
• Common Device Name: EXOFIN MASTIC
• Manufacturer (Section D): CHEMENCE MEDICAL; 200 technology dr; alpharetta GA 30005
• Manufacturer (Section G): CHEMENCE MEDICAL INC; 200 technology dr; alpharetta GA 30005
• Manufacturer Contact: hetal patel ; 200 technology dr; alpharetta, GA 30005
• MDR Report Key: 25608120
• Report Number: 3010034760-2026-00011
• Device Sequence Number: 14794761
• Product Code: KGX
• UDI-Device Identifier: 10854137001693
• UDI-Public: 0110854137001693
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D069034
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: EM80148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/24/2026
• 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: Other
• Patient Sex: Unknown