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

Model Number	PCOPM20
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: no product was returned for investigation.A video was provided.A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted.The visual examination of the provided video shows that: the video was done during an open surgery.The mesh is visible but due to the quality of the video we cannot confirm the textile pattern of the mesh, the dimension and ref.And the collagen film.A hole visibly in the middle of the mesh is shown.The reported condition was confirmed.This device was recalled under tracking number: z-0461-2019.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient was re-operated for ileus symptoms and hernia symptoms following a laparoscopic parastomal hernia repair.It was noted that the mesh was damaged.The mesh had a 3x3 cm hole close to the field when it's going from 3d to 2d structure.The incision was extended by more than 1 inch.They had to suture the hole in the mesh.

• 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: 8783200
• Report Number: 9615742-2019-02523
• Device Sequence Number: 1845829
• Product Code: FTL
• UDI-Device Identifier: 10884521177789
• UDI-Public: 10884521177789
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Device Lot Number: PPE0509X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention