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

Model Number	PCO2H3
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/06/2020
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 a laparoscopic repair of hiatus hernia, the mesh was placed upside down.The surgeon placed the adhesion reducing the film side on the diaphragm side and placed the mesh side on the organ side.

• 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: 10355277
• Report Number: 9615742-2020-01748
• Device Sequence Number: 3624341
• Product Code: FTL
• UDI-Device Identifier: 10884521178465
• UDI-Public: 10884521178465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040998
• 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): 08/03/2020

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: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: PCO2H3
• Device Catalogue Number: PCO2H3
• Device Lot Number: PSC0201X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1