BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 534441 · Received July 13, 2004

    Report

    Report Number
    2528909-2004-00015
    Event Type
    Injury
    Date Received
    July 13, 2004
    Date of Event
    June 24, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A PT WAS TREATED WITH FREEZE OFF, ONE APPLICATION ON WART LOCATED ON LEFT THUMB. THE NEXT MORNING THE FAMILY MEMBER OF THE PT NOTICED THE BURNS IN THE TREATED AREA AND TOOK THE PT TO BURN CENTER. PHYSICIAN TREATED WITH SILICONE AND A GAUZE WITH MEDICATION ON IT, DRESSED AND BANDAGED. FAMILY MEMBER REPORTS BURN SIZE AS 2 INCHES LENGTH AND 1 INCH WIDTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF CRYOSURGICAL WART TREATMENT SYSTEM GEH ORASURE TECHNOLOGIES, INC. * 1203ED4021

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other