BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER EX2

    MDR report key: 17488563 · Received August 9, 2023

    Report

    Report Number
    MW5121262
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Report Date
    May 18, 2023
    Manufacturer
    INVACARE CORPORATION
    Product Code
    IOR
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER ALLEGED A MANUFACTURER INVACARE TRACER EX2 WHEELCHAIR, SERIAL NUMBER (B)(6) WITH REDUCED BRAKE FORCE. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. REFERENCE NUMBER: (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
    2099714 TRACER EX2 WHEELCHAIR, MECHANICAL IOR INVACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown