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

Model Number	TECR1410DP2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
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, when they were about to place the mesh in the inguinal space on a laparoscopic totally extraperitoneal procedure, they noticed that a 1-2 cm defect was present on the mesh.The surgeon used an alternate mesh to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: a review of the device history has been performed and no failure that may relate to the reported conditions have been noted.The visual examination of the provided picture shows a ¿prosthesis opened and not used/implanted form¿ of the private hospital (b)(6).The mesh was indicated ¿deemed unsuitable when implanted¿.The reported condition could not be confirmed by this examination.No pictures relative to the defect were provided.The reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.If information is provided in the future, a supplemental report will be issued.

• 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: 8119290
• Report Number: 9615742-2018-02630
• Device Sequence Number: 229065
• Product Code: FTL
• UDI-Device Identifier: 10884521180062
• UDI-Public: 10884521180062
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: 03/31/2023
• Device Model Number: TECR1410DP2
• Device Catalogue Number: TECR1410DP2
• Device Lot Number: SSC1149M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR