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

Model Number	PP1208DL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Frequency / Polyuria (2275); Deformity/ Disfigurement (2360); Abdominal Distention (2601); Dysuria (2684); Constipation (3274); Sexual Dysfunction (4510); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the mesh was implanted during a left inguinal hernia repair using the lichtenstein technique.The procedure involved a horizontalized left inguinal incision under locoregional anesthesia, opening of the fascia of the great oblique, dissection of the cord, resection of an external oblique hernia sac with peritoneal closure, placement and fixation of the prosthetic plate, and closure of the fascia and skin.Following the procedure, the patient experienced permanent stretching sensations on the left operated side, sensations of swelling that were flat to the touch, burning sensation in the urethra when ejaculating, rapid and intense pain when ejaculating, a feeling of having to urinate with slight pain in the prosthesis area despite an empty bladder, and constipation relieved by massaging at the level of the scar with an associated feeling of swelling.The patient also reported an inability to wear a tight pants belt without pain and apparent swelling at the lower abdomen on the left side.There was a temporary penis deformity after the operation, which resolved spontaneously, and intermittent pain on the operation side during the day for no apparent reason.It was noted that surgical intervention was done.
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.

• 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: 24421560
• Report Number: 9615742-2026-00217
• Device Sequence Number: 5878372
• Product Code: FTL
• UDI-Device Identifier: 10884521177659
• UDI-Public: (01)10884521177659(17)241031(10)STJ2945X
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: PP1208DL
• Device Catalogue Number: PP1208DL
• Device Lot Number: STJ2945X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 11/12/2019
• 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
• Patient Age: 51 YR
• Patient Sex: Male