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

Model Number	810041BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient followed for multiple sclerosis, currently on ocrevus.The patient is autonomous in walking and has a known neuro-bladder.She presented mixed urinary incontinence, predominantly effort, with also some imperiosities in the context of her neurovessie.A tvt-type suburethral sling was placed on date#1, with a favorable outcome: spontaneous urination, without difficulty or recurrence of incontinence.For a few months, the patient has reported the reappearance of a more marked emergency, associated with malodorous vaginal discharge.Endoscopic exploration was therefore programmed to eliminate erosion of the strip.
Additional Manufacturer Narrative
Device was not received.However, a review of general manufacturing records indicates that all products released during the relevant timeframe were manufactured in accordance with approved procedures and met established specifications during the manufacturing and quality release process.Based on the information available, no further action is required at this time.This complaint will be documented and monitored through post-market surveillance activities.If additional information becomes available, the investigation will be updated as necessary.The manufacturing number is (b)(4).

• Common Device Name: GYNECARE TVT RETROPUBIC DEVICE
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA 91361
• Manufacturer (Section G): CALDER MEDICAL SARL-NAUCHATEL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 23472387
• Report Number: 3003990090-2025-01711
• Device Sequence Number: 13385463
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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
• Device Model Number: 810041BL
• Device Lot Number: 3935674
• 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: 10/24/2025
• Initial Report FDA Received Date: 11/04/2025
• 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: Other
• Patient Sex: Female