BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QVC

    MDR report key: 10394372 · Received August 11, 2020

    Report

    Report Number
    2438477-2020-00036
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    June 29, 2020
    Report Date
    August 10, 2020
    Manufacturer
    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A ROLLATOR. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE FLING THIS REPORT IN AN OVERABUNDANCE OF CAUTION SINCE THE END USER HIT HER HEAD. WE WILL FILE A FOLLOW UP REPORT IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION. THE END-USER SAT ON THE DEVICE AFTER ENGAGING THE BRAKES. THE BACK "GAVE OUT" AND SHE FELL BACKWARDS. SHE SCRAPED HER KNEE AND HIT HER HEAD AND BACK. NO MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853521 QVC ROLLATOR ITJ DRIVE DEVILBISS HEALTHCARE IS THE INITIAL IMPORTER UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1