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

Model Number	PCO4VP
Medical Device Problem Codes	Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Emotional Changes (1831); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Distress (2329); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
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 ventral incisional hernia.It was reported that after implant, the patient experienced damages, injuries, failure of mesh, pain, suffering, emotional distress, diminished quality of life, abdominal pain, infection, adhesions, bowel obstruction, defective design, disability, mental anguish, loss in capacity to enjoy life, scar tissue, recurrence, and impairment.Post-operative patient treatment included hospitalizations, prolonged antibiotic therapy, surgeries, wound care, narcotics, partial removal of mesh, debridement of fatty tissue muscle and fascia, and irrigation.

• 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: 12217522
• Report Number: 9615742-2021-01796
• Device Sequence Number: 3779335
• Product Code: FTL
• UDI-Device Identifier: 10884521165700
• UDI-Public: 10884521165700
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 07/23/2021

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 Model Number: PCO4VP
• Device Catalogue Number: PCO4VP
• Device Lot Number: PRJ8439X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/23/2021
• 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