BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 3213483 · Received July 3, 2013

    Report

    Report Number
    2438477-2013-00013
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 7, 2013
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(4) HAS RECEIVED A PATIENT COMPLAINT ABOUT AN INCIDENT INVOLVING A ROLLATOR ALLEGEDLY IMPORTED AN DISTRIBUTED BY (B)(4). THE CLAIMANT'S DAUGHTER STATED THAT HER FATHER WAS IN THE BATHROOM AFTER HE FINISHED USING THE TOILET, THE FAMILY ASSISTED HIM TO STAND UP AND SIT ON THE ROLLATOR. IN THE COURSE OF EXITING THE BATHROOM, ONE OF THE FRONT WHEEL FORKS BROKE CAUSING THE CLAIMANT TO FALL BACKWARDS AND HIT HIS HEAD AND BACK. THE CLAIMANT WAS TAKEN TO A HOSPITAL AND DIAGNOSED WITH FRACTURED VERTEBRA. THIS MDR REPORT IS BASED ON THE INFORMATION PROVIDED BY THE CLAIMANT'S DAUGHTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306184 DRIVE MEDICAL ROLLATOR ITJ HL CORP. (SHENZHEN) 10215BL-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention