BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELCHAIR, MECHANICAL

    MDR report key: 17317228 · Received July 12, 2023

    Report

    Report Number
    MW5119360
    Event Type
    Other
    Date Received
    July 12, 2023
    Report Date
    June 29, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    IOR
    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 MEDLINE 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715206 WHEELCHAIR, MECHANICAL WHEELCHAIR, MECHANICAL IOR MEDLINE INDUSTRIES, LP - NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown