BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKASINS DEVICE

    MDR report key: 24764448 · Received April 1, 2026

    Report

    Report Number
    MW5186287
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Report Date
    March 27, 2026
    Manufacturer
    RXFUNCTION INC.
    Product Code
    ISW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED A PRODUCT REPORT INVOLVING A NON-(B)(6) PRODUCT AND ARE SENDING YOU THE INFORMATION IN ACCORDANCE WITH 21 CFR 803.22. BELOW IS A BRIEF DESCRIPTION OF THE INFORMATION RECEIVED: PATIENT REPORTED THAT THE WALKASINS DEVICES WORN ON THEIR SHOES WERE NOT CHARGING. IF YOU HAVE ANY QUESTIONS REGARDING THIS LETTER FOR MANUFACTURER NOTIFICATION, PLEASE DO NOT HESITATE TO CONTACT US. 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
    2031 WALKASINS DEVICE ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL ISW RXFUNCTION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown