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

Model Number	TEM1409GR
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Necrosis (1971); Myalgia (2238); Inadequate Pain Relief (2388)
Date of Event	12/01/2023
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
It was reported that during a double inguinal operation, a mesh was implanted and post-operative complications arose.The patient experienced repeated cruralgia, diffuse nerve pain around the operated area and loss of sensation in the foot.There was an inability to resume normal physical activity due to a permanently contracted psoas and muscular consequences on the right leg, along with a very deteriorated psychological state.The mesh reportedly healed poorly and moved onto the femoral bone and testicular cord, leading to a lack of blood supply to the testicle, necessitating emergency surgery.During the surgery, the testicle was found to be hemorrhaging with necrosis around it.Subsequent examinations revealed a lesion of the crural nerve under the area operated on for the inguinal hernia and subnormal blood flow in the femoral region.Despite treatment, attacks of cruralgia and muscular pain in the psoas and adductor magnus worsened.The patient underwent physiotherapy for the psoas and received anti-inflammatories and rest for cruralgia.An electromyogram was conducted, confirming the nerve lesion.The patient sustained permanent injuries.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21873468
• Report Number: 9615742-2025-00390
• Device Sequence Number: 12921867
• Product Code: FTL
• UDI-Device Identifier: 10884521177710
• UDI-Public: 10884521177710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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 Model Number: TEM1409GR
• Device Catalogue Number: TEM1409GR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown