MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX; MESH, SURGICAL, POLYMERIC

Model Number	TEC1410P5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during deployment of mesh on a transabdominal preperitoneal repair, the surgeon pulled the thread with usual power but it broke easily and could not deploy the mesh.The procedure was completed with another device.There was no patient injury.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 9218871
• Report Number: 9615742-2019-03496
• Device Sequence Number: 13999212
• Product Code: FTL
• UDI-Device Identifier: 10884521180055
• UDI-Public: 10884521180055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: TEC1410P5
• Device Catalogue Number: TEC1410P5
• Device Lot Number: SSA0858X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1