BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 16952518 · Received May 18, 2023

    Report

    Report Number
    2438477-2023-00052
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Report Date
    May 18, 2023
    Manufacturer
    HOMECARE ENTERPRISE CO., LTD
    Product Code
    INP
    UDI-DI
    00822383246123
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING AN ADJUSTABLE CANE SEAT BY AN END USER, WHO STATED "THE CLIP BROKE THAT HOLDS THE SEAT UP CAUSING THE SEAT TO COLLAPSE," REPORTEDLY RESULTING IN THE END USER FALLING AND GETTING INJURED. THE END USER DID NOT PROVIDE ANY DETAILS ON THE TYPE OR SEVERITY OF INJURY. DRIVE IS ATTEMPTED TO RETRIEVE THE PRODUCT MULTIPLE TIMES FOR INVESTIGATION BUT WAS UNABLE TO CONFIRM RETURN. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894852 DRIVE CANE SEAT INP HOMECARE ENTERPRISE CO., LTD RTL10365-ADJ 00822383246123

    Patients

    Seq Age Sex Outcome Treatment
    1 Female