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

Model Number	PCOPM20
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	Tissue Damage (2104); Obstruction/Occlusion (2422); No Code Available (3191)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, following a laparoscopic repair of a parastomal hernia procedure using a modified sugarbaker operative approach, the mesh was damaged.The surgeon observed a fracture of the mesh corresponding to the translucent stripe, where this originally covered the hernia defect.There was tissue damage and the patient experienced bowel obstruction as a result of the product problem.The surgical time was extended 30 minutes or more and the event also resulted to an extended patient hospital stay.The patient underwent reoperation for parastomal hernia to resolve the issue and to prevent permanent impairment.
Additional Manufacturer Narrative
Evaluation summary: the visual examination of the provided picture shows that, a hole is visible in the middle of the mesh.Tackers are placed well, the distance from the edge of the mesh was found conform.The bowel is passing through the middle of the mesh by the hole.As no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with quality assurance (qa) specifications for all product lots prior release to market.The root cause could not be determined.The report has been added to our product complaints database which is monitored for similar occurrences.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.No immediate action required.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: 7639304
• Report Number: 9615742-2018-01366
• Device Sequence Number: 19307714
• Product Code: FTL
• UDI-Device Identifier: 10884521177789
• UDI-Public: 10884521177789
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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: 08/31/2020
• Device Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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
• Patient Age: 38 YR