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

Catalog Number	810081L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994)
Date of Event	04/23/2026
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
A female patient underwent implantation of a trans-obturator tape (tot) sling on (b)(6) 2017 for stress urinary incontinence.On (b)(6) 2025, the patient presented with intense, localized vulvo-vaginal pain associated with a fold of the tot mesh exhibiting pre-erosive changes of the vaginal mucosa.Following case review and approval at a multidisciplinary uro-gynecology meeting, partial removal of the sub-vaginal portion of the tot strip was recommended.The patient underwent partial explantation of the device on (b)(6) 2026.

• 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 91361
• Manufacturer (Section G): CALDERA MEDICAL- ETHICON SARL; puits-godet 20; neuchatel, 2000 ; WZ 2000
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr,; suite 140; westlake village, CA 91361
• MDR Report Key: 25032672
• Report Number: 3003990090-2026-02065
• Device Sequence Number: 10261301
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• 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: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 810081L
• Device Lot Number: 3183762
• 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: 04/29/2026
• Initial Report FDA Received Date: 04/29/2026
• 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