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

Catalog Number	TVTRL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	03/13/2026
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
Severe postoperative pain to the right of urologic surgery: tvt implantation.Incident requiring hospitalization and a ct scan that does not find a wound in the adjacent organs and visualizes a minimal effusion.Recommendation to return home with prescription for pain management.Erosion of the tvt strip at the high right side.Comments pain present in the right leg fatigue and chronic pain nocturnal awakening for urgentry tenesme edc sick stop current patient status: necessity of two surgical interventions a few weeks later, taking into account an recurrence of endovesical tumor lesion, to avoid the risk of spinning endoperitoneal urothelial cells.Convalescent patient with next postoperative appointment in (b)(6) 2026.

• Brand Name: GYNECARE TVT EXACT
• Common Device Name: TVT-CAL- EXACT
• 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 ; SZ 2000
• Manufacturer Contact: ryan curran ; 4360 park terrace dr,; suite 140; westlake village 91361
• MDR Report Key: 25174648
• Report Number: 3003990090-2026-02076
• Device Sequence Number: 10199360
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: TVTRL
• Device Lot Number: 3944976
• Was Device Available for Evaluation?: No
• 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
• Date Device Manufactured: 02/25/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female