BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADEL OBS

    MDR report key: 2140782 · Received June 15, 2011

    Report

    Report Number
    1831750-2011-05951
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: CALF SUPPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE CALF SUPPORTS WERE WORN AND NOT HOLDING THE PATIENT'S WEIGHT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADEL OBS LABOR AND DELIVERY BED HDD STRYKER MEDICAL 4700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1