BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843202 · Received November 21, 2012

    Report

    Report Number
    1525712-2012-02301
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    November 20, 2012
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE OWNER'S MANUAL WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. IN SPEAKING WITH THE WITH THE CONSUMER, SHE STATED THAT SHE DID NOT HAVE THE SERIAL NUMBER OR MODEL NUMBER OF THE POWER CHAIR. THE CONSUMER WAS COMING INTO A NURSING HOME. THE SIDEWALK WAS BROKEN UP AND HAD UNEVEN SURFACE. THE CONSUMER WAS WEARING A SEAT POSITIONING STRAP. AS THE CONSUMER WAS DRIVING, THE POWER CHAIR WENT OVER THE SIDEWALK THE CHAIR TIPPED OVER, CAUSING THE CONSUMER TO ALLEGEDLY INJURE HER NECK AND SHOULDER. THE CONSUMER IS NOT AWARE OF HOW LONG SHE HAS HAD THE CHAIR. SHE BELIEVES THAT SHE HAS HAD IT SINCE (B)(6) OF THIS YEAR. THE CONSUMER DID GO TO THE HOSPITAL. THEY X-RAYED HER BACK, NECK, AND SHOULDER. THEY PROVIDED A PRESCRIPTION FOR A MUSCLE RELAXER AND PAIN. THE CONSUMER BELIEVES THAT SHE NEEDS THERAPY. THIS IS THE CONSUMERS'S FIRST POWER CHAIR. THE CONSUMER IS NOT USING THE POWER CHAIR CURRENTLY, HOWEVER, THE DEALER DID COME OUT AND DRIVE THE UNIT. THE CONSUMER STATED THAT THE ONLY THING THEY FOUND WAS THAT THE ARM WAS BROKEN. I ADVISED THE CONSUMER THAT IT DOES NOT SEEM LIKE THE UNIT MALFUNCTIONED. IT SEEMS THAT THE CAUSE OF THE INCIDENT WAS THE UNEVEN SIDEWALK. THE CONSUMER AGREED, BUT STATED THAT SHE WAS IN THE POWER CHAIR AND INJURED HERSELF. ALSO, THE DEALER WAS CONTACTED HOWEVER NO FURTHER INFORMATION HAS BEEN RECEIVED. IF ANY FURTHER INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CONSUMER ALLEGES SHE WAS RIDING DOWN A SIDEWALK AND WAS GOING SLOW WHEN HER POWER CHAIR HIT A CRACK IN THE CONCRETE AND HER POWER CHAIR FELL OVER AND SHE RECEIVED SHOULDER AND BACK AND NECK INJURIES. THE END USER HAS BEEN CONTACTED FOR FURTHER INFORMATION ON THIS INCIDENT. PLEASE REVIEW ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 Other