BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT

    MDR report key: 3881302 · Received June 18, 2014

    Report

    Report Number
    2210968-2014-07812
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE. AT 1 YEAR AND 4 MONTHS POST-OP, THE PATIENT EXPERIENCED MESH ERODING INTO THE BLADDER. IT WAS OPINED THAT THE BLADDER MAY HAVE BEEN PERFORATED AND NOT NOTED AT 4 MONTHS POST-OP WHEN THE PATIENT COMPLAINED OF PAIN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357627 GYNECARE TVT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention