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

Model Number	PCOPM15H35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Scarring (2061); Hernia (2240); Injury (2348); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic complaint report: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The patient underwent a laparoscopic lysis of adhesions laparoscopic parastomal hernia repair with mesh.He had revision surgery 1 years and 7 months post-surgery.The patient experienced pain, adhesions, re-herniation, exposed mesh, scarring.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of parastomal hernia.It was reported that after implant, the patient experienced adhesions, bowel had grown through the mesh, several areas of small bowel desoralization, pain, re-herniation, exposed mesh, and scarring.Post-operative patient treatment included revision surgeries, laparoscopic lysis of adhesions and laparoscopic parastomal hernia repair with mesh.
Additional Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt. due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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: 7457774
• Report Number: 9615742-2018-01021
• Device Sequence Number: 1160896
• Product Code: FTL
• UDI-Device Identifier: 10884521177765
• UDI-Public: 10884521177765
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 06/30/2019
• Device Model Number: PCOPM15H35
• Device Catalogue Number: PCOPM15H35
• Device Lot Number: POG0279X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 10/14/2019
• 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: Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 91