BEUDAMED
    FDA Adverse Event Other Summary report: N

    BANTAM MEDIUM

    MDR report key: 3452863 · Received October 25, 2013

    Report

    Report Number
    2183634-2013-00004
    Event Type
    Other
    Date Received
    October 25, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 8, 2013
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K123834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BANTAM MEDIUM INSTRUCTIONS FOR USE INCLUDES INSTRUCTIONS TO SUPPORT THE BACK WHEN ADJUSTING THE SEAT DEPTH. THE REPRESENTATIVE DID NOT CONSULT THE INSTRUCTIONS FOR USE PRIOR TO ADJUSTING THE SEAT DEPTH. ALTHOUGH THIS IS COVERED IN THE INSTRUCTIONS FOR USE, ALTIMATE MEDICAL IS ADDING A LABEL ON THE BACK OF THE UNIT STATING TO SUPPORT THE BACK WHEN ADJUSTING SEAT DEPTH AS AN ADDITIONAL PREVENTIVE MEASURE.

    Description of Event or Problem · 1

    ONE OF OUR INDEPENDENT REPS CONTACTED AMI AND STATED THAT WHILE HE WAS ADJUSTING THE SEAT DEPTH ADJUSTMENT ON THE BANTAM MEDIUM THAT THE BACK MOVES FREELY ONCE THE KNOBS ARE LOOSENED AND THAT BACK HIT HIM IN THE FOREHEAD CAUSING A SMALL CUT IN HIS FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548558 BANTAM MEDIUM 890.3110 ION ALTIMATE MEDICAL, INC. BANTAM MEDIUM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other