BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE

    MDR report key: 17167330 · Received June 20, 2023

    Report

    Report Number
    2438477-2023-00077
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    April 11, 2023
    Report Date
    July 14, 2023
    Manufacturer
    HOMECARE ENTERPRISE CO., LTD.
    Product Code
    INP
    UDI-DI
    00822383246123
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 THAT THE UNIT "COLLAPSED WHILE I WAS SITTING ON IT." THE END USER REPORTEDLY SUSTAINED A HEAD INJURY, WHICH REQUIRED TREATMENT IN THE EMERGENCY ROOM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    (B)(6) HEALTHCARE WAS NOTIFIED OF A COMPLAINT REGARDING AN ADJUSTABLE CANE SEAT BY AN END USER, WHO STATED THAT THE UNIT "COLLAPSED WHILE I WAS SITTING ON IT." THE END USER REPORTEDLY SUSTAINED A HEAD INJURY, WHICH REQUIRED TREATMENT IN THE EMERGENCY ROOM. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545463 DRIVE CANE INP HOMECARE ENTERPRISE CO., LTD. RTL10365-ADJ 00822383246123

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization