BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 17709371 · Received September 8, 2023

    Report

    Report Number
    3004034546-2023-00001
    Event Type
    Injury
    Date Received
    September 8, 2023
    Report Date
    September 8, 2023
    Manufacturer
    A & I INDUSTRIES LTD
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE DID THE FINAL QUALITY INSPECTION BEFORE DELIVERY. THE ROLLATOR MODEL PASSED THE STATIC LOAD TEST & FATIGUE TEST THAT WERE PERFORMED IN 2023/05 ACCORDING TO THE ISO 11199-2:2021.

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY AN END USER'S DAUGHTER, WHO STATED THAT THE "RIGHT HANDLE SUDDENLY BENT DOWN WHERE THE PLASTIC HANDLE MEETS THE METAL FRAME" AND REPORTED THAT HER MOTHER LOST HER BALANCE AND BROKE HER LEG. THE END USER WAS TAKEN TO THE HOSPITAL AND UNDERWENT A WEEK OF TREATMENT FOR HER INJURIES. DRIVE REQUESTED THE UNIT BE RETURNED FOR INVESTIGATION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501432 DRIVE ROLLATOR ITJ A & I INDUSTRIES LTD RTL10266

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization