BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3241894 · Received July 22, 2013

    Report

    Report Number
    1525712-2013-06040
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 2, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MALFUNCTION ALLEGED. THE END USER STATED THE LEG REST ARE NOT COMFORTABLE AND THE METAL CUTS INTO HER LEGS. END USER HAS EDEMA SECONDARY TO HER CONGESTIVE HEART FAILURE. EXTENT OF INJURIES UNKNOWN OTHER THAN SHE IS SEEKING MEDICAL INTERVENTION FOR PAIN MANAGEMENT REGIMENT AND THAT A CALLUS HAS DEVELOPED ON HER LOWER EXTREMITY.

    Description of Event or Problem · 1

    THE END USER STATED THE LEG REST ARE NOT COMFORTABLE AND THE METAL CUTS INTO HER LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340497 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSIV-HD

    Patients

    Seq Age Sex Outcome Treatment
    1 55 Other