BEUDAMED
    FDA Adverse Event Summary report: N

    CRUTCH

    MDR report key: 4151092 · Received October 8, 2014

    Report

    Report Number
    1531186-2014-04785
    Date Received
    October 8, 2014
    Report Date
    October 1, 2014
    Manufacturer
    HEALTHPLUS
    Product Code
    IPR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT DUE TO WHERE THE 2 METAL PIECES OF THE 8115T CRUTCH MEET, THE END USER SUSTAINED A CUT ON THE INSIDE OF HIS LEFT ARM, BY HIS ELBOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633387 CRUTCH 890.3150 IPR HEALTHPLUS 8115T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other