BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 505337 · Received January 7, 2004

    Report

    Report Number
    2528909-2004-00001
    Event Type
    Other
    Date Received
    January 7, 2004
    Date of Event
    December 14, 2003
    Report Date
    January 6, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER SELF TREATED A WART ON LEFT HAND. BLISTERS FORMED LATER THAT NIGHT. BURNING SENSATION REQUIRED ER VISIT. ATTENDING PHYSICIAN DIAGNOSED SECOND AND THIRD DEGREE BURNS AND PRESCRIBED SALVE AND OXYCODONE FOR PAIN. USER FOLLOWED DIRECTIONS BUT THE CRYOGEN SPRAYED EVEN WITHOUT USER TOUCHING APPLICATOR AFTER INITIAL CHARGING.

    Description of Event or Problem · 1

    PT SELF TREATED A WART ON LEFT HAND. BLISTERS FORMED LATER THAT NIGHT. BURNING SENSATION REQUIRED EMERGENCY ROOM VISIT. ATTENDING PHYSICIAN DIAGNOSED SECOND AND THIRD DEGREE BURNS AND PRESCRIBED SALVE AND OXYCODONE FOR PAIN. USER FOLLOWED DIRECTIONS BUT THE CRYOGEN SPRAYED EVEN WITHOUT USER TOUCHING APPLICATOR AFTER INITIAL CHARGING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention