BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILT IN SPACE

    MDR report key: 12438943 · Received September 8, 2021

    Report

    Report Number
    1525712-2021-00014
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    July 22, 2021
    Report Date
    August 10, 2021
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED IN AN ABUNDANCE OF CAUTION AS IT DOESN'T APPEAR THE WHEELCHAIR MALFUNCTIONED. INVACARE WAS MADE AWARE OF AN EVENT THAT TOOK PLACE IN THE (B)(6) INVOLVING A REA AZALEA TRANSIT WHEELCHAIR. IT WAS MANUFACTURED BY INVACARE (B)(4); ON OCT 15, 2010. INVACARE IS FILING THIS REPORT BECAUSE THE SOLARA WHEELCHAIR, MADE AT INVACARE OWNED BY (B)(4), AND SOLD IN THE U.S., HAS BEEN DETERMINED TO BE SIMILAR IN DESIGN TO THE REPORTED DEVICE. WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. IT IS UNKNOWN HOW LONG THE PATIENT WAS LEFT SITTING IN THE SUN, AND HOW, OR IF THE REA AZALEA CAUSED OR CONTRIBUTED TO THE EVENT. AS SOON AS THE REQUESTED INFORMATION AND THE DEVICE OR PARTS HAVE BEEN RECEIVED, THE INVESTIGATION WILL CONTINUE. THE REA AZALEA WHEELCHAIR HAS NOT BEEN RETURNED. IF MORE INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE FILED.

    Description of Event or Problem · 1

    INVACARE EUROPE, WAS NOTIFIED OF AN EVENT THAT TOOK PLACE WITH A REA AZALEA WHEELCHAIR. THIS RECORD WAS CREATED DUE TO THE SOLORA WHEELCHAIR BEING SIMILAR IS DESIGN AND WOULD LIKELY HAVE THE SAME OUTCOME. IT IS ALLEGED THE PATIENT BURNED THEIR FOOT ON THE REA AZALEA MANUAL WHEELCHAIR. THE INJURY RESULTED IN THE AMPUTATION OF THE LEFT BIG TOE. THE DOCTORS HAVE EXPRESSED THAT IT IS POSSIBLY DUE TO THE PATIENT RESTING THEIR FOOT ON THE TUBE THAT ATTACHES THE ENTIRE FOOTPLATE TO THE LEG REST WHICH BECAME HOT FROM THE SUN. IT IS UNKNOWN HOW LONG THE PATIENT WAS LEFT SITTING IN THE SUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338777 TILT IN SPACE WHEELCHAIR, MECHANICAL IOR INVACARE TAYLOR STREET NA:SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other