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 Codes	Erosion (1750); Urinary Tract Infection (2120); Prolapse (2475); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	05/14/2026
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
(b)(6) received an e-mail from the ethicon risk manager team stating the following: it was reported that the patient underwent a gynecological procedure on (b)(6) 2012 and tvt-o was implanted.It was reported that the patient experienced pelvic pain, hip pain, back pain, abdomen pain, frequent urinary tract infections, urinary incontinence, and bowel incontinence, vaginal prolapse and pain during intercourse.No additional information was reported.

• 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: 25173907
• Report Number: 3003990090-2026-02075
• Device Sequence Number: 10474418
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: 10705031062290
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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: 3404791
• 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: 05/14/2026
• 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 Sex: Female