BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 9884725 · Received March 26, 2020

    Report

    Report Number
    2438477-2020-00019
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    October 1, 2019
    Report Date
    March 26, 2020
    Manufacturer
    HOMECARE ENTERPRISE CO., LTD.
    Product Code
    IPS
    UDI-DI
    00822383246123
    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 CANE. PMS ASSOCIATE IS AWAITING RETURN OF THE DEVICE FOR EVALUATION AND PHONE INTERVIEW WITH CONSUMER FOR MORE INFORMATION. WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION BECAUSE SHE HIT HER HEAD. END-USER WAS AT THE BANK WAITING ON LINE SITTING ON THE CANE SEAT WHEN IT BROKE. SHE FELL ON HER TAILBONE AND HIT HER HEAD ON A BIG LONG TABLE. SHE WENT TO THE EMERGENCY ROOM AND TOOK X RAYS OF HER HEAD AND TAILBONE. SHE HAD NO BREAKS BUT LARGE BRUISE THAT WERE PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348135 DRIVE CANE IPS HOMECARE ENTERPRISE CO., LTD. RTL10365-ADJ 00822383246123

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other