BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILT IN SPACE

    MDR report key: 14619352 · Received June 7, 2022

    Report

    Report Number
    9616091-2022-00007
    Event Type
    Injury
    Date Received
    June 7, 2022
    Report Date
    May 10, 2022
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVACARE WAS MADE AWARE OF AN EVENT THAT TOOK PLACE IN FRANCE WITH A 9-MONTH OLD REA AZALEA WHEELCHAIR. INVACARE IS FILING THIS REPORT BECAUSE THE SOLARA 3G WHEELCHAIR MADE AT INVACARE OWNED INVAMEX AND SOLD IN THE U.S. HAS BEEN DETERMINED TO BE SIMILAR IN DESIGN TO THE REA AZALEA. THE INFORMATION WE HAVE IS THAT THE REA AZALEA WHEELCHAIR FUNCTIONED AS INTENDED. THE CAREGIVER DID NOT APPLY THE BRAKES CORRECTLY CAUSING THE WHEELCHAIR TO MOVE FORWARD. NO MALFUNCTION ALLEGED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 0

    A STAFF MEMBER HAD THE PATIENT OUT FOR A WALK USING A REA AZALEA WHEELCHAIR. WHEN THEY STOPPED, THE STAFF MEMBER THOUGHT THEY HAD APPLIED THE BRAKE, BUT THEY ONLY FLICKED THE HANDLES FORWARD, USING THE BRAKES AT THE WHEELS. THE CHAIR THEN MOVED FORWARD, AND THE FRONT WHEELS WENT OVER THE CURB CAUSING THE PATIENT TO BE THROWN FROM THE WHEELCHAIR. THIS RESULTED IN SIGNIFICANT BRUISING TO HER EYES, FOREHEAD, FACE, AND HANDS. SHE HAS A POSSIBLE FRACTURE TO HER NOSE, (UNCONFIRMED) A POSSIBLE CONCUSSION, AND SIGNIFICANT GRAZING TO THE FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321251 TILT IN SPACE WHEELCHAIR, MECHANICAL IOR INVAMEX NA:SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other