BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR, MECHANICAL

    MDR report key: 23905536 · Received December 29, 2025

    Report

    Report Number
    MW5181230
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Report Date
    December 18, 2025
    Manufacturer
    GF HEALTH PRODUCTS, INC.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    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 (B)(6), 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917714 WHEELCHAIR, MECHANICAL WHEELCHAIR, MECHANICAL IOR GF HEALTH PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown