BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICELOCK

    MDR report key: 18092004 · Received November 8, 2023

    Report

    Report Number
    3003764610-2023-00018
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    July 26, 2023
    Report Date
    November 8, 2023
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAS A PROSTHETIC LEG THAT DETACHED AS HE WAS WALKING. THE PATIENT FELL AND DISLOCATED HIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753771 ICELOCK PROSTHETIC LOCK ISH OSSUR HF

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other