BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUARDIAN CRUTCH

    MDR report key: 362755 · Received November 28, 2001

    Report

    Report Number
    2020334-2001-00022
    Event Type
    Other
    Date Received
    November 28, 2001
    Report Date
    November 28, 2001
    Manufacturer
    SUNRISE MEDICAL PCP DIVISION
    Product Code
    IPR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWS FELL OUT OF THE CUFF ASSEMBLE (SIDE OPENING CUFF) AFTER ONLY TWO WEEKS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53658 GUARDIAN CRUTCH FOREARM CRUTCH IPR SUNRISE MEDICAL PCP DIVISION 5160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other