BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2542409 · Received April 20, 2012

    Report

    Report Number
    1531186-2012-00141
    Date Received
    April 20, 2012
    Date of Event
    December 2, 2010
    Report Date
    April 9, 2012
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RETROSPECTIVE REVIEW OF THIS FILE BASED ON PROTOCOL (B)(4) DETERMINED THIS IS AN MDR. NO RMA HAD BEEN INITIATED FOR THIS ISSUE AT THE TIME OF THE INCIDENT. MODEL 65100-JR, (B)(4) WAS APPROXIMATELY 3 YEARS OLD AT THE TIME OF THE INCIDENT. THE OWNER'S MANUAL PART NUMBER 1150739 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL COULD ALSO BE FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAD FULLY READ AND UNDERSTOOD THE OWNER'S MANUAL. DOCUMENTATION PROVIDED WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DID NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD HAVE CONTACT INVACARE. THE CONSUMER WAS A (B)(6) FEMALE, (B)(6). AT THE TIME OF THE INCIDENT. 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 DAUGHTER-IN-LAW STATED THAT THE CONSUMER WAS INDOORS USING THE UNIT WHEN THE WHEEL ALLEGEDLY FELL OFF CAUSING THE CONSUMER TO FALL BACKWARDS AND HIT HER HEAD ON THE FLOOR. THE INCIDENT OCCURRED IN THE MIDDLE OF THE AFTERNOON. THIS IS THE FIRST TIME THAT THE WHEEL ALLEGEDLY FELL OFF AND THE CONSUMER HAS NOT HAD ISSUES PRIOR TO THIS INCIDENT WITH THE UNIT. THE CONSUMER DID HAVE A CAT SCAN DONE, BUT NO INJURIES WERE FOUND. THE CONSUMER HAS HAD THE UNIT FOR APPROXIMATELY TWO AND A HALF YEARS. INVACARE IS SENDING THE CONSUMER A REPLACEMENT UNIT AND THE DAMAGED ONE IS COMING BACK FOR AN INSPECTION. (B)(4). THE DEVICE, ROLLATOR, MODEL #65100-JR, LOT #GT071112 WAS RETURNED FOR AN EVALUATION. PRODUCT WAS APPROXIMATELY 3 YEAR OLD AT TIME OF INCIDENT. MAINTENANCE HISTORY IS UNKNOWN. THE CASTER STEM HEAD TUBE THREADS WERE STRIPPED. THIS FAILURE OCCURS WHEN THE DEVICE CONTINUES TO BE USED WITH THE STEM IN A LOOSENED CONDITION. THIS INCIDENT WAS DUE TO A LACK OF PROPER MAINTENANCE AND NOT A PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING ON THE SEAT AND THEN STOOD UP, WHEN THE PART WHERE THE RIGHT FRONT WHEEL WAS ATTACHED ALLEGEDLY BROKE, CAUSING THE CONSUMER TO FALL AND HIT HER HEAD. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL HOMECARE PRODUCTS 65100-JR GT071112

    Patients

    Seq Age Sex Outcome Treatment
    1 94 MO Other