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

Catalog Number	810041BL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	04/21/2026
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 55-year-old female patient being treated for multiple sclerosis complicated by neurogenic bladder, presenting with mixed urinary incontinence - predominantly stress incontinence[?]associated with urge incontinence.In this context, a tvt-type suburethral sling was implanted in april 2022.The course of the condition was marked in 2025 by the development of sling erosion at the level of the anterior vaginal wall.Surgical management was performed on (b)(6) 2025, consisting of partial removal of the sling via the vaginal route with excision of 12 mm of suburethral material.Subsequently, on (b)(6) 2026, a recurrence was observed with bilateral erosion of the sling on either side of the urethra, associated with protrusion of a few millimeters of sling into the vagina on each side.In light of this persistent complication, the decision was made to proceed with complete removal of the device.A robot-assisted laparoscopic procedure to remove both arms of the sling was performed on (b)(6) 2026.The device is available at the hospital pitié-salpetrière and in waiting to be returned.

• Brand Name: TVT GYNECARE RETROPUBIC
• 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: ryan curran ; 4360 park terrace dr,; suite 140; westlake village 91361
• MDR Report Key: 25166880
• Report Number: 3003990090-2026-02074
• Device Sequence Number: 10474079
• 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: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 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: 05/13/2026
• Initial Report FDA Received Date: 05/14/2026
• 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 Age: 55 YR
• Patient Sex: Female