BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC DISPOSABLE PACK

    MDR report key: 1491828 · Received September 2, 2009

    Report

    Report Number
    1037885-2009-00001
    Event Type
    Malfunction
    Date Received
    September 2, 2009
    Date of Event
    August 12, 2009
    Report Date
    August 1, 2009
    Manufacturer
    ADVANCE MEDICAL DESIGNS, INC.
    Product Code
    KKX
    PMA / PMN Number
    850959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION: SPD TECHNICIAN WENT TO PICK OEC [C-ARM] DISPOSABLE PACK FROM SHELF AND NOTICED THAT STERILE PACKAGING WAS NOT SEALED. TECHNICIAN THEN INSPECTED OTHER PACKS AND FOUND ANOTHER PACK WITH DEFECTIVE SEAL. THESE TWO UNITS WERE REMOVED FROM SERVICE. SEALS ON OTHER UNITS FROM SAME LOT WERE NOT DEFECTIVE. MANUFACTURER HAS BEEN NOTIFIED AND HAS REQUESTED DEFECTIVE PACKS BE RETURNED TO MFR. MFR RESPONSE (AS PER REPORTER) FOR C-ARM DRAPE OEC DISPOSABLE PACK. MFR REQUESTED THAT PRODUCT BE RETURNED TO MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC DISPOSABLE PACK DRAPE, C-ARM KKX ADVANCE MEDICAL DESIGNS, INC. 07-PK800 81062C8122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA