BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 1082167 · Received July 29, 2008

    Report

    Report Number
    3005720080-2008-00001
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    May 9, 2008
    Report Date
    July 12, 2008
    Manufacturer
    JIANGSU KONGSUNG MEDICAL EQUIP CO LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CANNOT DRAW A CONCLUSION, THAT'S WHY ONE CASTER CAME OFF, BUT THE OTHER ONE IS STILL VERY TIGHT ON THE LEG. IT MIGHT BE CAUSED BY STRONG VIBRATION ON THE RIGHT SIDE OF ROLLATOR DURING USE. WE WILL APPLY PROPER AMOUNT OF ANTI-LOOSE GLUE ON THE THREAD WHEN CASTER IS ASSEMBLED WITH THE FRAME. WE WILL ALSO INCREASE OUR QUALITY CONTROL TO MAKE SURE THE CASTER WILL NOT COME OFF.

    Description of Event or Problem · 1

    THE USER'S ATTORNEY NOTIFIED DRIVE MEDICAL, OUR DISTRIBUTOR IN THE US, OF CERTAIN INJURIES SUFFERED AS A RESULT OF THE ALLEGED ROLLATOR COLLAPSING THAT OCCURRED ON THE DAY OF THE EVENT. THE USER'S SON THEN CALLED TO DRIVE MEDICAL CUSTOMER SERVICE AND STATED THAT THE USER HAD A FRACTURED SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL ROLLATOR ITJ JIANGSU KONGSUNG MEDICAL EQUIP CO LTD R6BK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention