BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA BEDBAG

    MDR report key: 2903412 · Received December 14, 2012

    Report

    Report Number
    1018233-2012-02113
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A MDR SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACKAGING WAS PIERCED. THE PIERCE WAS DISCOVERED PRIOR TO BEING USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARDIA BEDBAG KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGWA1456

    Patients

    Seq Age Sex Outcome Treatment
    1