BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE WALKERS

    MDR report key: 1080418 · Received July 16, 2008

    Report

    Report Number
    1525712-2008-00063
    Event Type
    Injury
    Date Received
    July 16, 2008
    Date of Event
    May 31, 2008
    Report Date
    July 14, 2008
    Manufacturer
    INVACARE CORP. PATIENT AIDS MFG.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MFR RECEIVED A MED WATCH REPORT. NO SERIAL NUMBER HAS BEEN PROVIDED. AGE OF DEVICE AND MAINTENANCE HISTORY IS UNK. THE COMPLAINT, AS RECEIVED, INDICATES A BROKEN WHEEL. USER GUIDES ARE CLEAR IN INSTRUCTING AS TO THE PROPER AND SAFE USE OF THE PRODUCT. MDR FILED BASED ON MED WATCH FORM RECEIVED.

    Description of Event or Problem · 1

    THE MEDWATCH REPORT STATES "THE RESIDENT SAT ON THE WALKER SEAT AND ONE FRONT WHEEL BROKE OFF, CAUSING HER TO FALL". NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE WALKERS 890.3825 ITJ INVACARE CORP. PATIENT AIDS MFG. UNKWALK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention