BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLARA3G

    MDR report key: 12370372 · Received August 26, 2021

    Report

    Report Number
    9616091-2021-00010
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    July 2, 2021
    Report Date
    December 7, 2021
    Manufacturer
    INVAMEX MANUFACTURING
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING FILED BECAUSE THE ORIGINAL REPORT INCORRECTLY REPORTED THE REA AZALEA IS SIMILAR TO THE MYON WHEELCHAIR. THE REA ASSIST IS SIMILAR TO THE SOLORA WHEELCHAIR MADE AT INVACARE OWNED BY INVAMEX..

    Description of Event or Problem · 0

    INVACARE EUROPE WAS NOTIFIED OF AN EVENT THAT TOOK PLACE IN THE UNITED KINGDOM INVOLVING A REA AZALEA TRANSIT WHEELCHAIR. THE END-USER WAS TRAVELING IN A VEHICLE GOING APPROXIMATELY 5MPH WHEN IT HAD TO STOP ABRUPTLY. THE WHEELCHAIR'S LAP BELT IS REPORTED TO HAVE COME AWAY FROM THE WHEELCHAIR ON USER'S LEFT SIDE. IT WAS ALSO REPORTED THAT THEY WERE USING THE VEHICLE SEAT BELT, AND IT WAS SECURED WITH VEHICLE TIE DOWN EQUIPMENT. THE END-USER FELL FROM THE WHEELCHAIR CAUSING A SMALL CUT AND BRUISING TO LEFT EYEBROW, AND A FRACTURE OF LEFT LOWER LEG.

    Additional Manufacturer Narrative · 1

    INVACARE WAS MADE AWARE OF AN EVENT THAT TOOK PLACE IN (B)(6) INVOLVING A REA AZALEA TRANSIT WHEELCHAIR. IT WAS MANUFACTURED BY INVACARE (B)(4); IN JANUARY OF 2020. INVACARE IS FILING THIS REPORT BECAUSE THE MYON WHEELCHAIR, MADE AT INVACARE OWNED BY INVAMEX, AND SOLD IN THE U.S., HAS BEEN DETERMINED TO BE SIMILAR IN DESIGN TO THE REPORTED DEVICE. (B)(6) WHEELCHAIR REPAIR SERVICE ATTENDED AND RE-FITTED THE LAP BELT WITHIN ONE HOUR OF THE INCIDENT. THERE WAS NO DAMAGE NOTED ON THE BELT NOR THE WHEELCHAIR. IT IS UNCLEAR HOW THE LAP BELT COULD HAVE BECOME DETACHED FROM THE WHEELCHAIR WITHOUT BEING DELIBERATELY UNDONE. THE BELT HAD BEEN CORRECTLY FITTED AT TIME OF DELIVERY. THE INVESTIGATION IS ONGOING, A FOLLOWUP WILL BE FILED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    INVACARE EUROPE WAS NOTIFIED OF AN EVENT THAT TOOK PLACE IN (B)(6) INVOLVING A REA AZALEA TRANSIT WHEELCHAIR. THE END-USER WAS TRAVELING IN A VEHICLE GOING APPROXIMATELY 5MPH WHEN IT HAD TO STOP ABRUPTLY. THE WHEELCHAIR'S LAP BELT IS REPORTED TO HAVE COME AWAY FROM THE WHEELCHAIR ON USER'S LEFT SIDE. IT WAS ALSO REPORTED THAT THEY WERE USING THE VEHICLE SEAT BELT, AND IT WAS SECURED WITH VEHICLE TIE DOWN EQUIPMENT. THE END-USER FELL FROM THE WHEELCHAIR CAUSING A SMALL CUT AND BRUISING TO LEFT EYEBROW, AND A FRACTURE OF LEFT LOWER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267993 SOLARA3G WHEELCHAIR, MECHANICAL IOR INVAMEX MANUFACTURING NA:MYON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other