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

Model Number	810081
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Incontinence (1928)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
"patient in perpetual suffering chronic cystalgia and urinary infections very painful: since the placement of this strip repeated urinary infections, at least one per month.And more and more chronic cystalgia.".
Additional Manufacturer Narrative
An investigation could not be performed as the lot number associated with the reported event was not identified.Without a lot number, a review of device history records or production-specific data could not be conducted, thereby limiting the ability to perform a thorough root cause investigation.Based on the limited information provided, the reported product complaint could not be confirmed.

• Brand Name: TVT-CAL-OBTURATOR
• Common Device Name: "GYNECARE TVT OBTURATOR"
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr.; suite 140; westlake village CA 91361
• Manufacturer (Section G): ETHICAN SARL-NEUCHATEL; puits-godet 20; neuchatel 2000, ; WZ
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr.; suite 140; westlake village 91361
• MDR Report Key: 22997148
• Report Number: 3003990090-2025-01598
• Device Sequence Number: 13166751
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/08/2025

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
• Device Model Number: 810081
• Device Catalogue Number: TVT-CAL-OBTURATOR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown