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

Model Number	TET5050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: pco2015x parietex pcox 20x15 cm x1 (lot# png0659x), pco2015x parietex pcox 20x15 cm x1 (lot# poi0819x), unknown protack (lot# unknown).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 incisional hernia, and a parastomal hernia.It was reported that after implant, the patient experienced fistula, infection, abscess, pain, hernia recurrence, adhesions, limitations on physical activity, and emotional injuries without treatment.Post-operative patient treatment included revision surgery, bowel resection, transferred to bariatric bed and taken directly to icu, intubated/ventilated, and wound vac.

• 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: 11900529
• Report Number: 9615742-2021-01396
• Device Sequence Number: 19153300
• Product Code: FTL
• UDI-Device Identifier: 10884521180369
• UDI-Public: 10884521180369
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: 05/31/2017
• Device Model Number: TET5050
• Device Catalogue Number: TET5050
• Device Lot Number: SME00482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/28/2021
• 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; Disability