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

Model Number	TET1510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Distress (2329); Discomfort (2330); Injury (2348); No Code Available (3191)
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
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hernia.It was reported that after implant, the patient experienced recurrence; dense adhesions of the mesh to the esophagus, stomach, and retroperitoneum; severe pain and discomfort in the area of the implant; mental anguish; emotional distress.After treatment, the patient experienced revision surgery.
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.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a hiatal hernia.It was reported that after implant, the patient experienced recurrence, dense adhesions of the mesh to the esophagus, stomach, and retroperitoneum, severe pain and discomfort in the area of the implant, mental anguish, and emotional distress.After treatment, the patient experienced revision surgery, repair of recurrent paraesophageal hiatal hernia, toupet fundoplication, excision of stricture of parietex mesh from esophagus, and lysis of gastric adhesions to pancreas and liver.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 7878653
• Report Number: 9615742-2018-02094
• Device Sequence Number: 11277962
• Product Code: FTL
• UDI-Device Identifier: 10884521180345
• UDI-Public: 10884521180345
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 09/30/2016
• Device Model Number: TET1510
• Device Catalogue Number: TET1510
• Device Lot Number: SLJ00232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/21/2019
• 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
• Patient Age: 78 YR
• Patient Weight: 63