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

Model Number	PCOPM20
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Dehydration (1807); Purulent Discharge (1812); Fistula (1862); Foreign Body Reaction (1868); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917); Unspecified Infection (1930); Inflammation (1932); Liver Damage/Dysfunction (1954); Nausea (1970); Pain (1994); Renal Failure (2041); Scar Tissue (2060); Tachycardia (2095); Vomiting (2144); Electrolyte Imbalance (2196); Hernia (2240); Stenosis (2263); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Constipation (3274); Hyponatremia (4494); Renal Impairment (4499); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Sleepiness/Drowsiness/Somnolence (4850)
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 adhesions and recurrence.Post-operative patient treatment included revision surgery.It was noted that during implant procedure the mesh was cut through.
Additional Manufacturer Narrative
Additional information: a3a, a4, b5, b7, d6b, g1, h4, h6 (ime, imf, device codes).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 hernia.It was reported that after implant, the patient experienced adhesions, recurrence, enterotomy, mesh erosion, pain, infection, inflammation, obstructions, scar tissue, enterotomy, and succus.Post-operative patient treatment included revision surgery, gore-tex patch repair of hernia, cholecystectomy, removal of mesh, repair of enterotomy caused by mesh erosion, repair of ileal conduit opening, exploratory laparotomy, lysis of adhesions, succus removed from bowel, and medication.It was noted that during implant procedure the mesh was cut through.
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 adhesions, recurrence, mesh erosion, pain, infection, inflammation, obstructions, scar tissue, enterotomy, succus, labs abnormal for wbc; h & h; electrolyte derangement; coagulopathy; elevated creatinine (renal impairment); blood protein; high liver enzymes (liver damage/dysfunction), foreign body reaction, bacterial infection, hyponatremia, large fluid collection, air collection, acute kidney injury, abdominal pain, vomiting, ileus, nausea, acute renal failure, fistulous connection, urinoma, stenotic region, area of compromised tissue, systemic inflammatory response, cloudy foul smelling drainage, tachycardia, fevers, yellow drainage that looks like stool, purulent exudate, distention, constipation, dehydration, hypovolemic shock, low blood pressure, somnolence, & abdominal incisional wounds.Post-operative patient treatment included revision surgery, gore-tex patch repair of hernia, cholecystectomy, repair of enterotomy caused by mesh erosion, repair of ileal conduit opening, exploratory laparotomy, lysis of adhesions, succus removed from bowel, medication, mesh revision, removal of mesh, hospitalization, ct scan, cat scan, ng tube, iv hydration, symptomatic relief, bowel rest, use of drains, looposcopy, loopgram, foley catheter placement, iv antibiotics, drain management, urology consult, removal of tacks, icu, electrolyte repletion, lower abdominal wound care, reduction of hernia, & primary repair of hernia.
Additional Manufacturer Narrative
Additional info: a5b, b2, b5, b6, b7, d4 (unique identifier (udi) #), g1, h6 (patient codes, ime e2402: labs abnormal for wbc; h & h; coagulopathy; blood protein, air collection, ileus), & additional codes.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: mike bocchino ; 5920 longbow drive; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 8006464633
• MDR Report Key: 11846123
• Report Number: 9615742-2021-01267
• Device Sequence Number: 19639382
• Product Code: FTL
• UDI-Device Identifier: 10884521177789
• UDI-Public: (01)10884521177789(17)140228(10)PJC00623
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

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: 02/28/2014
• Device Model Number: PCOPM20
• Device Catalogue Number: PCOPM20
• Device Lot Number: PJC00623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 01/22/2025; 08/13/2025
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 01/27/2025; 08/28/2025
• Date Device Manufactured: 03/31/2009
• 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; Hospitalization; Life Threatening
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White