BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3821605 · Received May 20, 2014

    Report

    Report Number
    9616091-2014-00888
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 8, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT WHILE THE WHEEL LOCKS ON A (B)(4) WHEELCHAIR WERE LOCKED INTO PLACE THE CHAIR MOVED DURING A TRANSFER CAUSING THE END USER TO FALL. USER SUSTAINED INJURY TO HER RECENTLY BELOW THE KNEE AMPUTATION, CAUSING THE NEED FOR ADDITIONAL SURGERY, AMPUTATION ABOVE THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299284 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9SL

    Patients

    Seq Age Sex Outcome Treatment
    1 63 Hospitalization| O| R