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

Model Number	PCO3020FX
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Pain (1994); Scar Tissue (2060); Vomiting (2144); Dizziness (2194); Hernia (2240); Stenosis (2263); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Fluid Discharge (2686); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 (x2 parietex composite, product id - pco3020fx, lot # - pnf0082), <(>&<)> h6 ime e2402: induration, thickening at the abdominal wall.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.
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.It was reported that after implant, the patient experienced hernia recurrence, small bowel dilation, adhesions, stenosis of small bowel, induration, lump, mesh infection, fluid filled tract, scarring, thickening at the abdominal wall, staph, abdominal pain, mesh movement, pain with significant impact on all daily activities, unable to walk any distance from pain, nausea, light headedness, incision leaking haemoserous fluid, discharge of blood, <(>&<)> vomiting.Post-operative patient treatment included ct scan, ultrasound, abdominal split, <(>&<)> antibiotics.

• 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 ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20232637
• Report Number: 9615742-2024-01321
• Device Sequence Number: 8666841
• Product Code: FTL
• UDI-Device Identifier: 10884521179844
• UDI-Public: 10884521179844
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 09/16/2024

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: 03/31/2015
• Device Model Number: PCO3020FX
• Device Catalogue Number: PCO3020FX
• Device Lot Number: PND0321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 04/26/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 COMMENT
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Male
• Patient Weight: 104 KG