BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 534588 · Received July 13, 2004

    Report

    Report Number
    2528909-2004-00014
    Event Type
    Injury
    Date Received
    July 13, 2004
    Report Date
    July 12, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TWO PTS WERE TREATED WITH FREEZE OFF (ONE ON KNEE & ONE ON FINGER). BOTH PT'S DEVELOPED 2ND DEGREE BURNS FROM THE APPLICATIONS. A PT'S KNEE REQUIRED DAILY VISITS TO THE DOCTOR TO TREAT BURN AND CHANGE DRESSINGS. THE FAMILY MEMBER CALLED TO REPORT EVENT BUT ANOTHER RELATIVE APPLIED THE PRODUCT AND WAS NOT AVAILABLE FOR QUESTIONS. THE CANISTER LOT WAS NOT REPORTED.

    Description of Event or Problem · 2

    TWO PTS WERE TREATED WITH FREEZE OFF (ONE ON KNEE & ONE ON FINGER). BOTH PT'S DEVELOPED 2ND DEGREE BURNS FROM THE APPLICATIONS. A PT'S KNEE REQUIRED DAILY VISITS TO THE DOCTOR TO TREAT BURN AND CHANGE DRESSINGS. THE FAMILY MEMBER CALLED TO REPORT EVENT BUT ANOTHER RELATIVE APPLIED THE PRODUCT AND WAS NOT AVAILABLE FOR QUESTIONS. THE CANISTER LOT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF CRYOSURGICAL WART TREATEMENT SYSTEM GEH ORASURE TECHNOLOGIES, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other
    2 11 YR Other