BEUDAMED
    FDA Adverse Event Summary report: N

    CANES

    MDR report key: 2671898 · Received July 26, 2012

    Report

    Report Number
    1531186-2012-00609
    Date Received
    July 26, 2012
    Report Date
    July 24, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IPS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 3920-2, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1167530 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. THE CONSUMER IS AN (B)(6) FEMALE, (B)(6). THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMERS SON CALLED STATING THAT HIS MOTHER WAS WALKING OUT OF THE LUNCHROOM AT HER CHURCH, GOING TOWARDS THE PEWS, WHEN SHE ALLEGEDLY FELL. THE CONSUMER WAS TAKEN TO THE HOSPITAL AND ADMITTED WHERE SHE HAD SURGERY ON HER UPPER RIGHT ARM DUE TO HER BONE BEING SHATTERED. A ROD WAS PLACED INTO HER ARM. SHE WAS RELEASED FROM THE HOSPITAL AND PLACED IN A NURSING CARE FACILITY FOR APPROXIMATELY 2 MONTHS. THE INCIDENT OCCURRED ON (B)(6) 2012. THERE IS NO MENTION OF A MALFUNCTION WITH THE DEVICE. INVACARE'S CONSUMER AFFAIRS DEPARTMENT IS DILIGENTLY TRYING TO CONTACT THE SON FOR ADDITIONAL INFORMATION. THE CONSUMER HAS BEEN UTILIZING THIS DEVICE FOR APPROXIMATELY 6 YEARS.

    Description of Event or Problem · 1

    CONSUMER'S SON CALLED STATING THAT HIS MOTHER WAS WALKING OUT OF THE LUNCH ROOM IN CHURCH AND WENT TOWARDS THE PEW AND SHE FELL. NO MENTION OF A MALFUNCTION WITH THE DEVICE. SERIOUS INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANES 890.3075 IPS UNKNOWN 3920-2

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Hospitalization