BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT

    MDR report key: 3881478 · Received June 18, 2014

    Report

    Report Number
    2210968-2014-07816
    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. THE PATIENT EXPERIENCED POSTURAL PERINEAL PAIN ASSOCIATED WITH PERFORATION OF THE LOWER URINARY TRACT DUE TO SLING INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357732 GYNECARE TVT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention