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

Model Number	PP1208DR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Unspecified Kidney or Urinary Problem (4503); Unintended Radiation Exposure (4565); Swelling/ Edema (4577)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: pp1208dl, pp1208dl progrip lt ppl/pla 12x8cm (lot#:szg1682x) 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
According to the reporter the patient underwent a cure of a bilateral inguinal hernia using the modified tension-free lichtenstein technique with mesh implantation on (b)(6) 2025.The patient had an abdominal computed tomography scan without injection on (b)(6) 2025.There was a slight subcutaneous infiltration regarding the perioral site without an organized collection.Absence of unmasked hernia during pushing maneuvers.The patient had a consultation following an abdominal computed tomography scan without injection for a pelvic pain assessment, with radiation in the penis essentially nocturnal and associated with frequent urination.The ct scan did not find anything.The physical advised the patient to get in touch with a urologist.On (b)(6) 2026, the patient had another consultation due to the problem of a painful, persistent, and disabling symptomatology.Examination of the external genitalia revealed no abnormalities, and the wall healing was satisfactory.The clinical prostate examination was reassuring, as was the urine dipstick test and the ultrasound check of bladder emptying.In the event of post-operative ilioinguinal neuralgia.A magnetic resonance imaging (mri) with pelvic injection was performed, showing edematose infiltration of soft tissues along bilateral inguinal surgical approa ches and at the level of the proximal orifices of the sperm cords.Severe, congestive left hip osteoarthritis with synovitis.Currently persistent sensations of uncomfortable heaviness and tightness in the pubic area and penis increased at night a month and a half after the surgery, requiring treatment with medications for 1 month.A ct scan, mri and ultrasound were performed, which showed significant edema at the level of the operating site.Evolution towards a progressive partial improvement and cessation of treatments, except paracetamol.Absence of fever, urinary tract infection and biological inflammation syndrome.

• 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 ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24935887
• Report Number: 9615742-2026-00447
• Device Sequence Number: 10727512
• Product Code: FTL
• UDI-Device Identifier: 10884521177666
• UDI-Public: (01)10884521177666(17)300630(10)SZG0170X(20)10
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PP1208DR
• Device Catalogue Number: PP1208DR
• Device Lot Number: SZG0170X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/21/2026
• Date Device Manufactured: 07/03/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Sex: Male