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	Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Dysuria (2684); Sexual Dysfunction (4510)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, there were urinary problems postoperatively: pain during urination, significant difficulty urinating, and slight incontinence during exercise.The patient immediately felt very strong abdominal pain, mainly in the scars, which corresponded to the attachment points, and pain and discomfort in the urethra and vagina.The patient also noted an intravaginal foreign body sensation and was still experiencing dysuria.Quickly, lumbar, sacroiliac, and gluteal pain was also felt, a bit like sciatica.These pains became more pronounced until they became unbearable, and insomnia with difficulty walking.The patient went to the hospital and had a loco-dolenti infiltration with xylocaine 1% 10 ml.Post-infiltration examination confirmed a positive block.This infiltration was catastrophic; the patient could no longer walk, completely blocked in the pelvis, and this amplified the pain.Currently, the patient still has urinary problems: stinging sensations in the urethra, burning, dysuria, difficulty urinating, and the sensation of an intravaginal foreign body with pain that has an impact on sexual intercourse.Abdominal pain is also still present and much more intense, very important when walking but also when sitting.The sacroiliac, lumbar, and gluteal pain are still present; they have become more pronounced and aggravated.The patient was often stuck on the pelvis.The pain in the lower back and buttocks was so unbearable that the patient had trouble standing.
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: 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: 22216441
• Report Number: 9615742-2025-00734
• Device Sequence Number: 8158390
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: 12/31/2020
• Device Model Number: TECGK06
• Device Catalogue Number: TECGK06
• Device Lot Number: SQA0120X
• 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: 05/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Date Device Manufactured: 01/16/2016
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown