BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 17019119 · Received May 30, 2023

    Report

    Report Number
    2438477-2023-00048
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Report Date
    June 1, 2023
    Manufacturer
    COM-DA HEALTHCARE CO.,LTD
    Product Code
    ITJ
    UDI-DI
    00822383117331
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A WALKER BY AND END USER'S WIFE, WHO STATED "HER HUSBAND FELL DOWN" WHILE USING THE WALKER. THE REPORTER STATED THAT THE WALKER'S LEG WAS BENT, BUT WAS UNSURE WHETHER THE LEG WAS BENT PRIOR TO THE FALL, OR AS A RESULT OF THE FALL. SHE CONFIRMED THAT HER HUSBAND DID NOT SUSTAIN ANY INJURIES, AND DID NOT SEEK ANY MEDICAL TREATMENT. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING A WALKER BY AND END USER'S WIFE, WHO STATED "HER HUSBAND FELL DOWN" WHILE USING THE WALKER. THE REPORTER STATED THAT THE WALKER'S LEG WAS BENT, BUT WAS UNSURE WHETHER THE LEG WAS BENT PRIOR TO THE FALL, OR AS A RESULT OF THE FALL. SHE CONFIRMED THAT HER HUSBAND DID NOT SUSTAIN ANY INJURIES, AND DID NOT SEEK ANY MEDICAL TREATMENT. DRIVE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541777 DRIVE WALKER ITJ COM-DA HEALTHCARE CO.,LTD 10200-1 00822383117331

    Patients

    Seq Age Sex Outcome Treatment
    1 Male