BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE CHANNEL DRAIN

    MDR report key: 3934675 · Received June 25, 2014

    Report

    Report Number
    1018233-2014-00158
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 30, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRAIN BROKE OFF IN THE PATIENT WHEN BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371886 SILICONE CHANNEL DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention