BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2993441 · Received March 7, 2013

    Report

    Report Number
    9616091-2013-00386
    Date Received
    March 7, 2013
    Report Date
    February 6, 2013
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE BACK OF THE WHEELCHAIR IS CUTTING INTO THE BACK OF THE PATIENT. THE EXTENT OF THE INJURY AND USER'S MEDICAL CONDITIONS ARE UNKNOWN. THE REPORTER REFUSED TO GIVE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96926 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other