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

Model Number	P152030
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Aspiration/Inhalation (1725); Bacterial Infection (1735); Cyst(s) (1800); Purulent Discharge (1812); Emotional Changes (1831); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Renal Failure (2041); Sepsis (2067); Seroma (2069); Vomiting (2144); Hernia (2240); Stenosis (2263); Injury (2348); Deformity/ Disfigurement (2360); Impaired Healing (2378); Obstruction/Occlusion (2422); Respiratory Failure (2484); Fluid Discharge (2686); Aspiration Pneumonitis (4455); 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 hernia.It was reported that after implant, the patient experienced recurrence and pain.Post-operative patient treatment included removal surgery.
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 abscess, cyst, inflammation, infection, adhesions, bowel obstruction, bleeding, seroma, discharge drainage, recurrence and pain.Post-operative patient treatment included medication, removal surgery, exploratorylaparotomy extensive lysis of adhesions, hernia repair with new mesh.
Additional Manufacturer Narrative
Additional information: a4, b5, b7, h6 (patient codes), 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.
Additional Manufacturer Narrative
Additional information: b2, b5, d4, h6(patient codes, device codes), 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.
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 abscess, cyst, inflammation, infection, adhesions, bowel obstruction, bleeding, seroma, discharge drainage, recurrence, mesh failure, disability, disfigurement, loss of enjoyment of life, and pain.Post-operative patient treatment included medication, removal surgery, exploratory laparotomy extensive lysis of adhesions, hernia repair with new mesh.
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 abscess, cyst, inflammation, infection, adhesions, bowel obstruction, bleeding, seroma, discharge drainage, recurrence, mesh failure, disability, disfigurement, loss of enjoyment of life, pain, mrsa, tight stenosis of small bowel, abdominal pain, nausea, vomiting, minor aspiration, bowel twisted, aspiration pneumonitis, respiratory failure, acute renal failure, sepsis, purulent drainage from wound, <(>&<)> chronically draining area.Post-operative patient treatment included medication, mesh revision, partial mesh removal, removal surgery, exploratory laparotomy extensive lysis of adhesions, hernia repair with new mesh, hospitalization, intubation, removal of hernia sac, icu level care, antibiotics, dialysis, prolonged ventilatory support, nutrition via gastric tube, tracheostomy, rehab, component separation, use of drains, wound care, blood transfusion, removal of cyst, <(>&<)> debridement <(>&<)> cauterization of infected area.
Additional Manufacturer Narrative
Additional info: a1, b2, b5, b6, b7, d4 (model #, catalog #), d6a, h6 (patient codes), <(>&<)> 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: PERMACOL
• Common Device Name: MESH, SURGICAL
• 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 ; 8200 coral sea st ne; 8200 coral sea st ne; mounds view,mn, CT 55112-4391 ; 8006464633
• MDR Report Key: 9121985
• Report Number: 9615742-2019-03168
• Device Sequence Number: 2333468
• Product Code: FTM
• UDI-Device Identifier: 10884523000122
• UDI-Public: (01)10884523000122(17)110914(10)08B0209
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/23/2026

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: 09/14/2011
• Device Model Number: P152030
• Device Catalogue Number: P152030
• Device Lot Number: 08B0209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 04/09/2025; 09/03/2025; 04/08/2026
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 04/15/2025; 09/11/2025; 04/23/2026
• 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; Life Threatening; Disability; Hospitalization
• Patient Sex: Female
• Patient Weight: 107 KG