BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDE® MVP® DURA SUBSTITUTE

    MDR report key: 3961918 · Received July 28, 2014

    Report

    Report Number
    3007284313-2014-00062
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 7, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    GXQ
    PMA / PMN Number
    K021477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT PROVIDED AND THEREFORE A REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED.ADDITIONAL INFORMATION; PATIENT INFORMATION (IDENTIFIER, AGE, GENDER, AND WEIGHT), DATE OF EVENT, DEVICE LOT NUMBER, AND PATIENT CONDITION (HOW THE PATIENT IS DOING NOW) WAS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD TETHERED CHORD SYNDROME AND THE PHYSICIAN USED GORE PRECLUDE® MVP DURA SUBSTITUTE TO CLOSE THE DURA. SUBSEQUENTLY, AFTER DURA CLOSURE THERE WERE ADHESIONS THAT REQUIRED AN INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438117 GORE PRECLUDE® MVP® DURA SUBSTITUTE DURA SUBSTITUTE GXQ W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other