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

Catalog Number	TVT-CAL-RETROPUBIC
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
"patient says: electric shock pains in the stomach (symptoms much less at the time i make this statement), inability to walk for about 4 months, from the evening of the operation, tingling in the right buttock and all along the right lower limb to the right foot 3 weeks after surgery (symptoms much lesser at the time i make this statement), groin pain (very rare now), vomiting on date#1 in the evening in hospital.Persistent or newer symptoms: lumbar and pelvic pain, recurrent urinary tract infections (weekly) since date#2, dyspareunia, chronic vaginal pain (deep burns type), "probable urethral erosion" according to translabial ultrasound performed at tenon hospital on date#3, presence of "two long wires whose origin is unknown" according to fiberscopy performed at tenon hospital on date#4.Impossibility of carrying loads of more than 3 kilograms, more sports, difficulty standing more than thirty minutes, difficult sexual intercourse, taking antibiotics very often (consequences on my liver?".
Additional Manufacturer Narrative
A review of the design history file for the lot number 3943526 was conducted in accordance with internal complaint handling procedures.No anomalies or deviations were identified, and the device was confirmed to meet all design and manufacturing specifications.No design-related issues were found that could be associated with the reported symptoms.Based on the limited information, the complaint could not be confirmed as related to a device deficiency.

• Brand Name: TVT-CAL-RETROPUBIC
• Common Device Name: "GYNECARE TVT RETROPUBIC DEVICE"
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr.; suite 140; westlake village 91361
• Manufacturer (Section G): ETHICAN SARL-NEUCHATEL; puits-godet 20; neuchatel, ; WZ
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr.; suite 140; westlake village, CA 91361 ; 8188796555
• MDR Report Key: 22820251
• Report Number: 3003990090-2025-01604
• Device Sequence Number: 8756802
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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 Catalogue Number: TVT-CAL-RETROPUBIC
• Device Lot Number: 3943526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female