BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 534443 · Received July 13, 2004

    Report

    Report Number
    2528909-2004-00013
    Event Type
    Injury
    Date Received
    July 13, 2004
    Report Date
    July 9, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A PT WAS TREATED WITH ONE APPLICATION OF FREEZE OFF FOR A WART LOCATED ON RIGHT WRIST. THE TIP OF THE APPLICATOR WAS PLACED AGAINST THE WART AND THE VALVE DEPRESSED. THE DAY OF THE TREATMENT CUSTOMER SOUGHT MEDICAL TREATMENT AT THE EMERGENCY ROOM AND SAW DOCTOR THE NEXT DAY. THE EMERGENCY ROOM PHYSICIAN TREATED WITH COLD COMPRESSES AND THE REGULAR PHYSICIAN PRESCIBED PAIN RELIEVERS AND BURN CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF CRYOSURGICAL WART TREATMENT SYSTEM GEH ORASURE TECHNOLOGIES, INC. * 5727

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other