MAUDE Adverse Event Report: CALDERA MEDICAL INC. GYNECARE TVT OBTURATOR W LASR; TVT-CAL-OBTURATOR

Model Number	810081L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Pelvic Pain (4865)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed leg, pelvis, hip, lower back, painful left, burn very complicated to put foot on the floor, complication for walking.
Additional Manufacturer Narrative
The investigation is ongoing and the results will be reported soon.The internal manufacture's complaint number is (b)(4).
Additional Manufacturer Narrative
Investigation results: an analysis of the product could not be performed since a physical sample was not received for evaluation."a manufacturing record evaluation was performed for the finished lot number 3944988 (product code 810081l), and no non-conformances / manufacturing irregularities were identified.Expiration date: 28.Feb.2026 manufacturing date : 26.Mar.2025" as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition; therefore, it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable the manufacturing number is c26-3021.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Common Device Name: TVT-CAL-OBTURATOR
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr.; suite 140; westlake village CA
• Manufacturer (Section G): CALDER MEDICAL; sarl-nauchatel; puits-godet 20; neuchatel 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; puitis-godet 20; suite 140; neuchatel, 2000 ; WZ 2000
• MDR Report Key: 24236477
• Report Number: 3003990090-2026-02024
• Device Sequence Number: 9184422
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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 Expiration Date: 02/28/2026
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3944988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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: Required Intervention
• Patient Sex: Female