BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSUR ICEROSS LINER

    MDR report key: 547241 · Received January 14, 2004

    Report

    Report Number
    3003764610-2004-00001
    Event Type
    Injury
    Date Received
    January 14, 2004
    Date of Event
    November 30, 2003
    Report Date
    January 14, 2004
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    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

    THE ICEROSS COMFORT LINER IS USUALLY THE FIRST COMPONENT IN A PROSTHETIC LEG. IT IS ROLLED ON TO THE RESIDUAL LIMB, AND IS MADE OF A SOFT, STRETCHY MATERIAL THAT ACTS AS AN INTERFACE BETWEEN THE HARD, WEIGHT-BEARING SOCKET AND THE SKIN. THE LINER PROTECTS THE LIMB AND ACTS AS AN ATTACHMENT TO THE PROSTHESIS. OSSUR ICEROSS COMFORT LINER IS AN OSSUR PRODUCT AND IS PRODUCED AT OSSUR HF. CO DOES NOT HAVE ANY INFO ABOUT WHAT TYPES (OSSUR OR SOMEONE ELSE'S PRODUCTS) OF OTHER COMPONENTS WERE USED IN THE PROSTHETIC LEG. ALL FOLLOWING INFO WAS RECEIVED FROM CO'S CONTACT PERSON, THE PROSTHETIST: DESCRIPTION OF EVENT: THE PT WAS WALKING AT THEIR HOUSE WHEN THE DISTAL ATTACHMENT TORE OUT OF THE LINER. THE PROSTHETIST THINKS THAT THE PT FELL FORWARD, SINCE THEY PUT THEIR HANDS OUT TO CATCH THEMSELVES BUT THEY ALSO SAID THAT THERE WAS NO WAY TO CONCLUDE HOW THE PT FELL. WHEN THEY FELL, THEY BROKE THEIR WRIST. CO DOES NOT HAVE ANY INFO ABOUT WHY OR HOW THEY FELL, NOR WHAT BROKE IN THEIR WRIST. THE PT'S WRIST WAS PUT IN A SEMI-RIGID BRACE AND THEN LATER IN A CAST. NO FURTHER INFO IS AVAILABLE REGARDING THE TREATMENT. THE PT HAS OTHER HEALTH PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSSUR ICEROSS LINER FORMFITTING SILICONE INTERFACE/COVER FOR LOWER LIMB AMPUTE ISH OSSUR HF ICEROSS COMFORT LINER (LOCKING) 0137, 01=2001, 37=WEEK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention OSSUR ICEROSS LINER (TO 2003).