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

Model Number	PCOPM20
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, following a laparoscopic parastomal hernia repair procedure, the implanted mesh was damaged.A re-operation was done to resolve the issue and the patient's hospital stay was extended.
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 parastomal hernia repair procedure using sugarbaker technique, the patient has experienced pain when walking and during stoma defecation.A laparoscopic re-operation was done where in it was found that the mesh was damaged.A supplementary open local revision of the ostomy was also done following the laparoscopic part wherein five centimeters of bowel was excised.There was also an extension on the patient's hospital stay.

• 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: 8019615
• Report Number: 9615742-2018-02502
• Device Sequence Number: 1755713
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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 Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 72