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

Catalog Number	TVT-CAL-OBTURATOR
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pelvic Pain (4865)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of the incident: serious pelvic pain, difficult to walk, repeated tendonitis, chronic fatigue.

• Brand Name: TVT-CAL-OBTURATOR
• Common Device Name: GYNECARE TVT OBTURATOR W LASR
• Manufacturer (Section D): CALDERA MEDICAL; 4360 park terrace dr.; suite 140; westlake village 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: 22898568
• Report Number: 3003990090-2025-01608
• Device Sequence Number: 8957841
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• 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): 08/26/2025

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 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: 08/26/2025
• 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: Female