BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 4781943 · Received May 19, 2015

    Report

    Report Number
    2210968-2015-06046
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    April 24, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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 THE PATIENT UNDERWENT SLING PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED EXPOSURE OF THE MESH OF LESS THAN 1 CM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325422 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention