BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 540873 · Received August 25, 2004

    Report

    Report Number
    2528909-2004-00018
    Event Type
    Injury
    Date Received
    August 25, 2004
    Date of Event
    July 25, 2004
    Report Date
    August 24, 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
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT SELF-TREATED WITH FREEZE OFF, WART LOCATED ON TOP OF INDEX FINGER. CUSTOMER WENT TO ER FOR TREATMENT, DATE UNK. CUSTOMER REPORTS THAT ATTENDING PHYSICIAN'S DIAGNOSIS WAS ACID BURN. CUSTOMER WAS GIVEN SOMETHING FOR THE PAIN AND SENT HOME. CUSTOMER HAS NOT RETURNED PRODUCT FOR TESTING. CUSTOMER'S DESCRIPTION OF USE INDICATES THAT THE DIRECTIONS WERE NOT FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOUND W FREEZE OFF CRYOSURGICAL WART TREATMENT SYSTEM GEH ORASURE TECHNOLOGIES, INC. * 5826 41221458

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other