BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 495748 · Received November 13, 2003

    Report

    Report Number
    2528909-2003-00003
    Event Type
    Other
    Date Received
    November 13, 2003
    Report Date
    November 7, 2003
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT WENT THROUGH 40 SECOND TREATMENT AND FINGER BLISTERED IMMEDIATELY. BLISTER BURST OPEN THE NEXT DAY. INFECTION DEVELOPED IN OPEN BLISTER OVER NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF CRYOSURGICAL WART TREATMENT SYSTEM GEH ORASURE TECHNOLOGIES, INC. * 0503

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention