BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBTURATOR

    MDR report key: 23407545 · Received October 28, 2025

    Report

    Report Number
    3003990090-2025-01688
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    December 10, 2012
    Report Date
    November 18, 2025
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    UDI-DI
    10705031000346
    PMA / PMN Number
    K201686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING, AND THE RESULTS WILL BE REPORTED. THE MANUFACTURING NUMBER IS C25-2886.

    Additional Manufacturer Narrative · 0

    CORRECTION: B1, H1, ADDTIONAL INFORMATION: D5, E1, H6, H11. H11: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THE MANUFACTURING NUMBER IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2005, AND GYNECARE TVT-E WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND PROTRUSION, RECTOCELE, CYSTOCELE, EROSION, AND EXTRUSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2006 AND ANOTHER REMOVAL SURGERY OF MESH ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587831 GYNECARE TVT OBTURATOR TVT-CAL-OBTURATOR OTN CALDERA MEDICAL INC. 810081 297961 10705031000346

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention