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

Model Number	810081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Urinary Incontinence (4572); Pelvic Pain (4865)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Based on the available information, it has been determined that no corrective or preventive action will be proposed at this time.This complaint will be documented and monitored through post-market surveillance activities.If additional information becomes available, the investigation will be updated as necessary.Internal manufacturing number is (b)(4).
Event or Problem Description
It was reported an issue concerning the trans obturator tension-free vaginal tape (tvt-o).The purpose of the report was to demonstrate that the overall success rate of the treatment exceeded 75% among women undergoing tvt-o surgery for stress urinary incontinence (sui).However, 5.3% of patients experienced pain, 1% developed mesh erosion, 2.3% experienced voiding dysfunction, and 7% reported abnormal voiding at discharge.
Additional Manufacturer Narrative
Additional information: h11.Correction g1.Investigation results: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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: (b)(4).

• Brand Name: GYNECARE TVT OBTURATOR
• 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 ; puits-godet 20; suite 140; neuchatel, 2000 ; WZ 2000
• MDR Report Key: 24139951
• Report Number: 3003990090-2026-02011
• Device Sequence Number: 12105068
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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 Model Number: 810081
• Device Catalogue Number: 810081
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/12/2026
• 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: Other
• Patient Sex: Female