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

Model Number	TCM1106X3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348); Abdominal Distention (2601); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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.Events: the patient had surgical revision.External contact is not available in source document.
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.New information shows that the product within this report was not used or otherwise involved in the reported issue.No further reports will be sent for this product event.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 an epigastric ventral hernia.It was reported that after implant, the patient experienced recurrence, bulging, and pain.Post-operative patient treatment included surgical revision and repair of recurrent hernia with new mesh.
Additional Manufacturer Narrative
Regulatory report # 9615742-2017-05699 sent on 3/10/2019 stated this event was no longer reportable.However, a review of additional information determined this is now a reportable event.All fields of this report have been updated and corrected to reflect the case as described to us by the customer.Additional info: a4, b5, d8, e1 (facility name, street, city, region, postal code), h4, h6 (updated all codes, added patient codes and imf code).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PARIETEX
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 60 middletown ave; 8200 coral sea st ne; mounds view,mn, CT 55112 ; 7635265677
• MDR Report Key: 7027544
• Report Number: 9615742-2017-05699
• Device Sequence Number: 1005035
• Product Code: FTL
• UDI-Device Identifier: 10884521178847
• UDI-Public: 10884521178847
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2024

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: 08/31/2014
• Device Model Number: TCM1106X3
• Device Catalogue Number: TCM1106X3
• Device Lot Number: SJI00248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 10/20/2017; 05/08/2024
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 10/03/2019; 05/14/2024
• Date Device Manufactured: 09/18/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 95 KG