BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 6666902 · Received June 26, 2017

    Report

    Report Number
    2438477-2017-00054
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    May 10, 2017
    Report Date
    May 29, 2017
    Manufacturer
    MASS CORPORATION
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    (B)(4) RECEIVED NOTIFICATION OF AN INCIDENT INVOLVING A ROLLATOR THAT (B)(4) IMPORTS AND DISTRIBUTES. THE PATIENT WAS USING THE ROLLATOR WHEN ALLEGEDLY HE FELL CAUSING HIM TO BREAK HIS FEMUR. HE WAS TAKEN TO THE ER WHERE HE UNDERWENT SURGERY. THE PATIENT'S DAUGHTER REQUESTED A FULL CREDIT FOR THE ROLLATOR. (B)(4) IS IN THE PROCESS OF OBTAINING THE UNIT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448343 DRIVE MEDICAL MECHANICAL WALKER ITJ MASS CORPORATION 795BU

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other