BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN

    MDR report key: 2111865 · Received November 4, 2008

    Report

    Report Number
    3006459587-2008-00071
    Event Type
    Other
    Date Received
    November 4, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 27, 2008
    Manufacturer
    EASY TEC
    Product Code
    INP
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILED CRUTCH WILL BE RETURNED TO SUNRISE FOR EVAL BUT HAD NOT BEEN RECEIVED AS OF REPORT DATE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INJURING HERSELF WHILE USING A PAIR OF GUARDIAN CRUTCHES. FROM DISCUSSION WITH END USER, SHE THINKS THE DETENT PIN USED TO ADJUST THE HEIGHT OF THE CRUTCH FELL OUT AND THE CRUTCH GAVE WAY CAUSING HER TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN QUICK-FIT CRUTCH INP EASY TEC 51314-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other