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

Model Number	TEM3015G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Pelvic Inflammatory Disease (2000); Urinary Tract Infection (2120); Hernia (2240); Fungal Infection (2419)
Date of Event	03/13/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, a treatment of rectocele and elytrocele vaginally was done.Placement of a plate attached to the four cardinal corners and reinforcing the vaginal wall.Longitudinal colpotomy and incision of the vaginal fork were also done.In 2016, there was a recurrence of eventration of the abdominal wall operated by laparoscopic approach.It was noted that the exploration finds a large area of supra and periumbilical weakness with areas of disinsertion of the initial prosthesis.Suturing and an insertion of a prosthesis cut with adapted to the size of the eventration were done.In 2019, the patient experienced significant pain in lower lumbar and pelvic headaches corresponding to headaches on prosthetic material placed vaginally in 2015.Promontofixation was done.In 2021, the patient's condition has deteriorated a lot.Pelvic and lower back pain and burning were almost permanent and treated with a tramadol tablet every 12 hours.A repeated urinary tract infections (uti), even two per month despite one sachet of monuril per week.In addition, since (b)(6) 2024 fungal infections every month treated with fluconazole.The patient has difficulty walking with stiff joints and permanent fatigue and slow transit with very difficult manual defecation.
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.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21368075
• Report Number: 9615742-2025-00121
• Device Sequence Number: 8564584
• Product Code: FTL
• UDI-Device Identifier: 10884521177741
• UDI-Public: 10884521177741
• 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 Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 09/30/2020
• Device Model Number: TEM3015G
• Device Catalogue Number: TEM3015G
• Device Lot Number: SPI0938X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/12/2025
• Date Device Manufactured: 10/07/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female