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

Model Number	TEM2015G
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Deformation (2976); 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); Erosion (1750); Emotional Changes (1831); Fistula (1862); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Hernia (2240); Nodule (4551); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product: tem1509g parietex progrip tem/pla 15x9 cm(lot#: unknown).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 the implant, the patient experienced failure of mesh, mesh migration, mesh protruding through skin, abdominal pain, pain, chronic inflammation, bowel necrosis, fistula, extensive bowel adhesion, bowel deserosalization, bowel erosion, enterotomy, defective mesh, mental pain, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included corrective medical care, bowel resection, and removal surgery.
Additional Manufacturer Narrative
Additional info: a2 (date of birth), a3a, a4, b5, b7, d4 (expiration date, lot #), h4, h6 (patient code).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 an incisional hernia.It was reported that after the implant, the patient experienced extruded mesh, recurrence, folded mesh, failure of mesh, mesh migration, mesh protruding through skin, abdominal pain, pain, chronic inflammation, bowel necrosis, fistula, extensive bowel adhesion, bowel deserosalization, bowel erosion, enterotomy, defective mesh, mental pain, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included corrective medical care, bowel resection, and removal surgery.
Additional Manufacturer Narrative
Additional info: a1, a5b, b5, b6, b7, d4 (unique identifier (udi) #), g1, 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 a laparoscopic therapeutic treatment of an incisional hernia.It was reported that after the implant, the patient experienced extruded mesh, recurrence, folded mesh, failure of mesh, mesh migration, mesh protruding through skin, abdominal pain, pain, chronic inflammation, bowel necrosis, fistula, extensive bowel adhesion, bowel deseasonalization, bowel erosion, enterotomy, defective mesh, mental pain, disability, impairment, loss of enjoyment of life, hypertrophic scarring, <(>&<)> mass.Post-operative patient treatment included corrective medical care, mesh revision, bowel resection, removal surgery, <(>&<)> imaging.

• Brand Name: PROGRIP
• 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 55112-4391 ; 8006464633
• MDR Report Key: 12954813
• Report Number: 9615742-2021-02462
• Device Sequence Number: 20041222
• Product Code: FTL
• UDI-Device Identifier: 10884521177734
• UDI-Public: (01)10884521177734(17)210228(10)SQC0413X
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 02/06/2026

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: 02/28/2021
• Device Model Number: TEM2015G
• Device Catalogue Number: TEM2015G
• Device Lot Number: SQC0413X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/04/2024; 01/28/2026
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/09/2024; 02/06/2026
• Date Device Manufactured: 03/30/2016
• 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 H10
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White