MAUDE Adverse Event Report: CHEMENCE MEDICAL EXOFIN HIGH VISCOCITY TISSUE ADHESIVE

Model Number	EX70410
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incoming inspection records were reviewed and no non-conformances related to connector mold or any other type of weakness within the component were observed.Approximately 80 retain samples were inspected from this lot, but all components were intact.Customer complaint files were reviewed and there we no previous complaints related to this type of issue.No pictures were provided by the customer to review where the connector piece broke off.No corrective actions have been implemented at this time.
Event or Problem Description
The user stated that part of the applicator connector piece broke off during a procedure.

• Brand Name: EXOFIN HIGH VISCOCITY TISSUE ADHESIVE
• Common Device Name: TISSUE ADHESIVE
• Manufacturer (Section D): CHEMENCE MEDICAL; 200 technology dr.; alpharetta,
• MDR Report Key: 10441687
• Report Number: 3010034760-2020-00002
• Device Sequence Number: 4059978
• Product Code: MPN
• UDI-Device Identifier: 00854137001153
• UDI-Public: 010085413700115310066M317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2020

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
• Operator of Device: No Information
• Device Expiration Date: 11/22/2021
• Device Model Number: EX70410
• Device Lot Number: 0066-M3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1