BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 534123 · Received July 12, 2004

    Report

    Report Number
    2528909-2004-00012
    Event Type
    Other
    Date Received
    July 12, 2004
    Report Date
    July 9, 2004
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INCIDENT REPORTER STATES THAT A PT HAD A WART ON THEIR THUMB TREATED WITH FREEZE OFF. EXPERIENCED PAIN AND BLISTERING ON BOTH SIDES OF THUMB AFTER ONE TREATMENT. CUSTOMER SOUGHT MEDICAL ATTENTION (DOCTOR'S NAME/INFORMATION UNKNOWN). DOCTOR DIAGNOSED AS CHEMICAL BURN AND PRESCRBED PAIN MEDICATION. THE FAMILY MEMBER OF THE TREATED/INJURED PT APPLIED THE FREEZE OFF, FAMILY MEMBER IS UNAVAILABLE TO ANSWER QUESTIONS CONCERNING THE APPLICATION METHOD.

    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 * Other