BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 534142 · Received July 12, 2004

    Report

    Report Number
    2528909-2004-00010
    Event Type
    Injury
    Date Received
    July 12, 2004
    Report Date
    July 8, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER MEDICAL HISTORY: ANEURYSM, TAKING HEART MEDICATION (ZERTEX, NORVASAT, ZOLOFT). TREATED PLANTAR WART LOCATED ON BOTTOM OF RIGHT FOOT. INITIAL COMPLAINT WAS REPORTED AS CANISTER VALVE STUCK OPEN AND ENTIRE CONTENTS OF CANISTER SPRAYED ON FOOT. LOT NUMBER OF CANISTER REPORTED BY CUSTOMER DOSE NOT MATCH CO'S LOT NUMBERING SYSTEM. CUSTOMER SOUGHT MEDICAL ATTENTION (DOCTOR'S NAME/INFORMATION UNKNOWN). DOCTOR CUT LOOSE SKIN OFF FOOT FROM BROKEN BLISTER. CUSTOMER REPORTS THAT THEY WERE IN A CAR ACCIDENT AND HAS NO MEMORY OF ANY DETAILS. IN 2004 THE CUSTOMER REPORTS THAT THE FOOT IS STILL BEING TAPED UP, AND THE DRESSING CHANGED EVERY 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. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other