MAUDE Adverse Event Report: CALDERA MEDICAL INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PRODUCT; TVT-CAL-OBTURATOR

Catalog Number	TVTOBTUNK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Urinary Tract Infection (2120)
Date of Event	08/07/2025
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
Dir (b)(4) was received from the therapeutic goods administration (tga) concerning the tvt[?]o transobturator midurethral sling indicated for the treatment of urinary incontinence.The device was implanted on (b)(6) 2009, with no date of explantation provided.The patient, with a known history of two midurethral sling implants and a prior related report for the other sling, was referred for investigation due to recurrent urinary tract infections.Clinical assessment, including flexible cystoscopy and fluoroscopic urodynamic studies, identified vaginal mesh erosion involving both midurethral slings.Based on these findings, explant surgery is being planned.No additional information is available, as reporter details have not been disclosed for confidentiality reasons.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PRODUCT
• Common Device Name: TVT-CAL-OBTURATOR
• 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: 25125999
• Report Number: 3003990090-2026-02072
• Device Sequence Number: 18825731
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: TVTOBTUNK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/08/2026
• 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