BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIT JUNIOR WHEELCHAIR

    MDR report key: 17530987 · Received August 12, 2023

    Report

    Report Number
    MW5137903
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    June 23, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MERITS HEALTH PRODUCTS INC
    Product Code
    INI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AS REQUIRED BY THE US FDA FOR MEDICAL DEVICE DISTRIBUTORS, THIS LETTER IS TO INFORM, THE FDA, THAT INVACARE - ELYRIA, OH HAS BEEN CONTACTED REGARDING THE ABOVE REFERENCED DEVICE IN AN ALLEGED INCIDENT THAT OCCURRED ON OR ABOUT ON (B)(6) 2011. MERITS HEALTH PRODUCTS. INC., REGISTRATION NUMBER: (B)(4) HAS ALSO BEEN NOTIFIED REGARDING THIS INCIDENT. DETAILS INCLUDE: (B)(6), A PRE-EXISTING DOUBLE AMPUTEE, WAS USING THE WHEELCHAIR ON A HANDICAP SIDEWALK WHEN IT ALLEGEDLY TIPPED OVER. THE WHEEL CHAIR LANDED ON TOP OF THE USER. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727804 MERIT JUNIOR WHEELCHAIR VEHICLE, MOTORIZED 3-WHEELED INI MERITS HEALTH PRODUCTS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown