BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICEROSS COMFORT

    MDR report key: 548042 · Received September 23, 2004

    Report

    Report Number
    3003764610-2004-00003
    Event Type
    Injury
    Date Received
    September 23, 2004
    Date of Event
    June 30, 2003
    Report Date
    September 16, 2004
    Manufacturer
    OSSUR HF
    Product Code
    ISY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IC
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2003, PT WAS WALKING IN THEIR BACK YARD, WHEN THE LINER GAVE WAY CAUSING PT TO FALL WHICH RESULTED IN A SHOULDER INJURY AND SUBSEQUENT SURGERY. LEFT SHOULDER REPAIR SEEMS TO HAVE BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICEROSS COMFORT FORMFITTING SILICONE INTERFACE/COVER FOR LOWER LIMB AMPUTEE ISY OSSUR HF I-540625 *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention COMBINED PROSTHETIC LEG.