BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRW BIOPSY PLUS

    MDR report key: 2950311 · Received February 6, 2013

    Report

    Report Number
    1222895-2013-00006
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K032054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A REPORT WAS REC'D INVOLVING A CRWBP WHICH WAS DESCRIBED AS FOLLOWS; THE PHYSICIAN REPORTED THAT THERE ISN'T ANYTHING WRONG WITH THE FRAME ITSELF AND ISN'T CERTAIN THAT THE PROBLEM HE EXPERIENCED WITH THE BIOPSY WAS THE CAUSE FOR THE PT TO HEMORRHAGE. IT APPEARS THAT ONCE THE NEEDLE GOES INTO THE TARGET THAT THE NEEDLE DOESN'T LOCK INTO POSITION MAKING IS APPEAR THAT IT SLIPPED OUT OF PLACE AND POSSIBLY CAUSED A PROBLEM AT THE TARGET SITE (MID BRAIN STEM). HE FEELS THAT THERE MAY BE A DESIGN FLAW WITH THE PRODUCT. THE PT HEMORRHAGE AND SET HIM BACK NEUROLOGICALLY. THE PT WAS DISCHARGED BUT, HAS NOT FULLY REGAINED HIS NEUROLOGICAL CAPACITY SINCE THIS INCIDENT OCCURRED LATE IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50587 CRW BIOPSY PLUS NA HAW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR