BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 6046730 · Received October 21, 2016

    Report

    Report Number
    2438477-2016-00052
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 22, 2016
    Manufacturer
    MAX HEALTH
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) RECEIVED NOTICE OF AN INCIDENT INVOLVING A ROLLATOR THAT (B)(4) IMPORTS AND DISTRIBUTES. THE END USER WAS SITTING ON THE UNIT AT A BUS STOP, WHEN ALLEGEDLY ONE OF THE LEGS COLLAPSED CAUSING HIM TO FALL TO THE GROUND. HE WAS TAKEN TO THE HOSPITAL WHERE HE WAS GIVEN A SHOT FOR HIS BACK AND KEPT OVERNIGHT. NO FURTHER INJURIES WERE DISCLOSED. THE ITEM WAS RETURNED TO THE STORE IT WAS ORIGINALLY PURCHASED FROM AND WILL BE SHIPPED TO (B)(4) FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699543 DRIVE ROLLATOR ITJ MAX HEALTH R726BL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization