BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENNIS ELBOW ECLIPSE

    MDR report key: 1546122 · Received November 20, 2009

    Report

    Report Number
    2020250-2009-00002
    Event Type
    Injury
    Date Received
    November 20, 2009
    Date of Event
    October 5, 2009
    Report Date
    November 19, 2009
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE STATES "DO NOT APPLY HEATED GEL PAD DIRECTLY TO SKIN. IF TOO HOT, ALLOW TO COOL BEFORE APPLYING." THE INSTRUCTIONS FOR USE WILL BE CHANGED FROM 20 TO 10 SECOND HEATING INTERVALS JUST AS A FURTHER PRECAUTION IN ADDITION TO THE OTHER WARNINGS (I.E. NOT WEAR DIRECTLY AGAINST THE SKIN AND TO ALLOW TO COOL BEFORE APPLYING). THIS IFU IS SCHEDULED FOR IMMEDIATE PRINTING.

    Description of Event or Problem · 1

    PATIENT WARMED UP A TENNIS ELBOW ECLIPSE IN THE MICROWAVE FOR 10 SECONDS AND AFTER WEARING THE PRODUCT NOTED A LARGE RED SPOT AND BLISTER WHERE THE PRODUCT HAD BEEN. THE BLISTER LATER POPPED AND REQUIRED TREATMENT BY IN-HOUSE PHYSICIAN. REP STATED THAT THE PATIENT HAD FULLY RECOVERED FROM THE BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENNIS ELBOW ECLIPSE TENNIS ELBOW BRACE IQI OSSUR AMERICAS E310000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention