BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER

    MDR report key: 2243922 · Received September 6, 2011

    Report

    Report Number
    1056127-2011-00014
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    July 15, 2011
    Report Date
    September 6, 2011
    Manufacturer
    PINGHU ASPEL TECH CORP
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FRONT CASTER DETACHED FROM PT'S WALKER AND HE REINSERTED IT INTO THE FRAME. TWO TO THREE DAYS LATER THE FRONT CASTER BENT TOWARD THE REAR OF THE UNIT AS HE WAS WALKING IN HIS HOME. NO FALL, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER ROLLATOR ITJ PINGHU ASPEL TECH CORP LRA-300FBD

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR