BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 534161 · Received July 12, 2004

    Report

    Report Number
    2528909-2004-00009
    Event Type
    Other
    Date Received
    July 12, 2004
    Date of Event
    May 23, 2004
    Report Date
    July 12, 2004
    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

    IN 2004, A PT SELF-TREATED ONE WART LOCATED ON PALM SIDE OF LEFT HAND. CUSTOMER REPORTS A RED, PATCHY AREA ON THE OPPOSITE SIDE OF HAND FROM TREATED AREA. CUSTOMER SAYS THAT THE AREA IS NUMB AND THEY EXPERIENCE PAIN WHEN BENDING KNUCKLE ON LEFT THUMB. CUSTOMER WAS SEEN BY A DOCTOR 2 DAYS LATER, PHYSICIAN EVALUATED AREA AND ASKED THE CUSTOMER TO COME BACK IN A WEEK FOR FURTHER EVALUATION. CUSTOMER HAS NOT RETURNED TO DOCTOR FOR FOLLOW-UP. LAST CONTACT WITH CUSTOMER THE FOLLOWING DAY, THEY REPORT THAT THEY DEVELOPED A BLISTER IN THE TREATED AREA, THE HAND IS STILL DISCOLORED, THERE IS A DARK BROWN SPOT ON THEIR KNUCKLE AND THE TREATED AREA IS RED. CUSTOMER ALSO STATED THAT THEIR THUMB STILL GOES NUMB AND THE INSIDE OF THUMB IS PURPLE.

    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 24 YR Other