BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 614837 · Received July 22, 2004

    Report

    Report Number
    2528909-2004-00017
    Event Type
    Other
    Date Received
    July 22, 2004
    Date of Event
    July 4, 2004
    Report Date
    July 21, 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

    A PT WAS TREATED WITH FREEZE OFF, ONE APPLICATION ON FIVE WARTS LOCATED ON PALM OF RIGHT HAND (PROXIMITY OF ONE WART TO ANOTHER IS UNK). FAMILY MEMBER APPLIED COMPOUND W FREEZE OFF TO ALL FIVE WARTS IN 2004. WITHIN AN HOUR THE TREATED AREA STARTED TO BLISTER. CUSTOMER RETURNED PRODUCT TO PHARMACY, LOT NUMBER NOT IDENTIFIED. SOUGHT MEDICAL ATTENTION THE 3RD DAY. ATTENTING PHYSICIAN DID NOT PRESCRIBE A TREATMENT. CUSTOMER WAS TO GO FOR A FOLLOW UP TO PHYSICIAN 2 DAYS LATER, RESULTS UNK.

    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 19 YR Other