MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT RETROPUBIC DEVICE; TVT-CAL-RETROPUBIC

Catalog Number	810041BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Urinary Retention (2119)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing, and the results will be reported as soon as they are available.The internal complaint's manufacture number is (b)(4).
Event or Problem Description
A patient reported: the implant was performed on (b)(6) 2023, and immediately upon awakening from the procedure i experienced severe pain in the right groin, along with difficulty standing and emptying my bladder.This pain has never resolved and has progressively spread into my hip, down my thigh, and below the knee.Despite numerous treatments attempted for pain relief, none have been effective, and i am currently on morphine.My functional capacity is severely limited: i can stand for no more than 15 minutes and walk for only 5 minutes, while sitting or lying down is extremely painful and causes severe insomnia.At night, i am forced to change position every two hours because i cannot tolerate maintaining any posture.For outdoor mobility, i must use a manual wheelchair.I also suffer from unbearable pain and significant difficulty with urination.Subsequent medical examinations revealed a large longitudinal erosion of the ureter, and a blue strip is visible by transparency through the vaginal wall.Since this intervention, which was presented as safe and quick, my quality of life has been devastatingly altered, and my life as a wife and mother of four children has been profoundly impacted.

• Brand Name: GYNECARE TVT RETROPUBIC DEVICE
• Common Device Name: TVT-CAL-RETROPUBIC
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr,; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL- ETHICON SARL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr,; suite 140; westlake village, CA 91361
• MDR Report Key: 25115503
• Report Number: 3003990090-2026-02070
• Device Sequence Number: 9218836
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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 Catalogue Number: 810041BL
• Device Lot Number: 3939518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female