BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN WOUND DRAIN

    MDR report key: 3877812 · Received June 2, 2014

    Report

    Report Number
    1018233-2014-00138
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 12, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BACK SURGERY AND A CHANNEL DRAIN WAS PLACED. UPON REMOVAL 3 DAYS LATER A PIECE OF THE DRAIN BROKE AND REMAINED IN THE PATIENT AND HAD TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321718 UNKNOWN WOUND DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention