BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 501279 · Received December 12, 2003

    Report

    Report Number
    2528909-2003-00006
    Event Type
    Other
    Date Received
    December 12, 2003
    Date of Event
    November 27, 2003
    Report Date
    December 10, 2003
    Manufacturer
    ORASURE TECHNOLOGIES, INC
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT SELF TREATED A WART ON HEEL IN 2003. BLISTER FORMED AT TREATED AREA, CLIENT WENT TO E.R. TWO DAYS LATER. DR EXAMINED AND DIAGNOSED 2ND AND 3RD DEGREE BURN. A TETANUS SHOT WAS ADMINISTERED AT THE E.R. INITIALLY REPORTED "SPRAYED FREEZE OFF ON HEEL", LATER CORRECTS STATEMENT THAT AN APPLICATOR WAS USED.

    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 67 YR Required Intervention