MAUDE Adverse Event Report: CALDERA MEDICAL TVT EXACT RETROPUBIC SYSTEM; TVTRL

Catalog Number	TVTRL
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	01/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing and the results will be reported when available.The manufacturing number is (b)(4).
Event or Problem Description
A patient underwent a gynecological surgical procedure on (b)(6) 2016, during which a tvt exact implant was used.The patient subsequently experienced a urinary tract infection, leaking, and a burning sensation.Revisional surgery was performed on (b)(6) 2022, due to mesh erosion.On (b)(6) 2023, the patient underwent a left-side sling mesh removal due to protrusion.A final removal surgery occurred on (b)(6) 2025, due to intense, stabbing pain.No additional information is available.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Common Device Name: TVTRL
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr,; suite 140; westlake village, CA 91361
• Manufacturer (Section G): CALDERA MEDICAL SARL NAUCHTEL; 43puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 24436584
• Report Number: 3003990090-2026-02038
• Device Sequence Number: 10393477
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TVTRL
• Device Lot Number: 3880344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/24/2026
• 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