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

Model Number	TECGK06
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Laceration(s) (1946); Pain (1994); Prolapse (2475)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: 174006 protack 5 mm disp in (lot #: p5a0447x).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 promontofixation procedure in 2015 using a mesh and tacker, following this, a subtotal colectomy was performed in 2016 due to colonic decompensation, and a recurrence of prolapse was noted in 2017, associated with pelvic floor collapse, vaginal gap and anal sphincter hypertonia.Additional surgery (richter¿s sacro-spinofixation and posterior perineorrhaphy) was conducted in 2017 with seemingly uneventful recovery.However, the patient's condition has since worsened, leading to chronic pain, fatigue, early disability retirement, financial hardship, and severely diminished quality of life.In 2018, the patient began experiencing severe bilateral neuropathic leg pain, now requiring significant rest to manage.Despite regular electromyography (emg) follow-ups and the neuropathy being classified as idiopathic.No corrective action or intervention from the healthcare facility has been reported to date.

• Brand Name: PROSUP
• 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: 22312350
• Report Number: 9615742-2025-00766
• Device Sequence Number: 18389405
• Product Code: FTL
• UDI-Device Identifier: 10884521177604
• UDI-Public: 10884521177604
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: TECGK06
• Device Catalogue Number: TECGK06
• Device Lot Number: SPB0624X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 03/05/2015
• 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 NOTE ON H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown