BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER EX2 WHEELCHAIR

    MDR report key: 17316434 · Received July 12, 2023

    Report

    Report Number
    MW5119346
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Report Date
    June 29, 2023
    Manufacturer
    INVACARE CORPORATION
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH (B)(6) IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A MANUFACTURER INVACARE TRACER EX2 WHEELCHAIR, SERIAL NUMBER (B)(6) THAT HAD REDUCED BRAKE FORCE. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).Y

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715192 TRACER EX2 WHEELCHAIR WHEELCHAIR, MECHANICAL IOR INVACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown