BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 540867 · Received August 25, 2004

    Report

    Report Number
    2528909-2004-00019
    Event Type
    Other
    Date Received
    August 25, 2004
    Date of Event
    July 18, 2004
    Report Date
    August 24, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT WAS TREATED WITH FREEZE OFF, WART LOCATED ON TIP OF RIGHT INDEX FINGER. PT WAS TAKEN TO THE ER ROOM SAME DAY AS TREATMENT, DIAGNOSIS WAS SECOND DEGREE BURN. CUSTOMER REPORTS THAT ATTENDING PHYSICIAN INITIALLY SENT PT HOME WITH INSTRUCTIONS TO WATCH FOR BLISTER, CUSTOMER RETURNED TO ER LESS THAN 12 HRS AFTER INITIAL VISIT. ON THE THIRD DAY, AFTER TREATMENT, THE PT WAS TAKEN TO DR FOR BLISTER TO BE DRAINED. THE TREATED AREA WAS COVERED WITH ANTIBIOTIC PADS AND GAUZE. THE PT WAS SEEN BY DR'S OFFICE EVERY OTHER DAY FOR DRESSING TO BE CHANGED. PRODUCT LOT IDENTIFICATION IS NOT POSSIBLE SINCE CUSTOMER RETURNED PRODUCT TO RETAIL STORE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other