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

Model Number	P151828
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Emotional Changes (1831); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Hernia (2240); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 unincorporated mesh, recurrence, adhesions, calcification, foreign body reaction, disfigurement, pain, impairment, loss of enjoyment of life, mental pain, disability.Post-operative patient treatment included removal of mesh, hernia repair with new mesh, lysis of adhesions, wound closure, wound vac.
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 allergic reaction, unincorporated mesh, recurrence, adhesions, calcification, foreign body reaction, disfigurement, pain, impairment, loss of enjoyment of life, mental pain, disability.Post-operative patient treatment included removal of mesh, hernia repair with new mesh, lysis of adhesions, wound closure, medication, wound vac.
Additional Manufacturer Narrative
Additional information: a2, a3, a4, b5, b7, d3, d4, 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.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced allergic reaction, unincorporated mesh, recurrence, adhesions, calcification, foreign body reaction, disfigurement, pain, impairment, loss of enjoyment of life, mental pain, disability.Post-operative patient treatment included scar revision, removal of mesh, hernia repair with new mesh, lysis of adhesions, wound closure, medication, wound vac.
Additional Manufacturer Narrative
Additional info: b5, b7.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; 116 avenue du formans; trevoux auvergne-rhone-alpes,fr GU11 1EJ; UK GU11 1EJ
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux auvergne-rhone-alpes,fr GU11 1EJ; UK GU11 1EJ
• Manufacturer Contact: mike bocchino ; parkmore business park west; galway, MN ; EI ; 8006464633
• MDR Report Key: 22159167
• Report Number: 9617613-2025-00004
• Device Sequence Number: 8683190
• Product Code: FTM
• UDI-Device Identifier: 10884523000191
• UDI-Public: (01)10884523000191(17)120831(10)09B0909
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K120605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• 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): 07/20/2026

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: 08/31/2012
• Device Model Number: P151828
• Device Catalogue Number: P151828
• Device Lot Number: 09B0909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 07/15/2026
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 01/09/2026; 07/20/2026
• 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: Disability; Required Intervention
• Patient Sex: Female
• Patient Weight: 205 LB