BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 3201401 · Received June 25, 2013

    Report

    Report Number
    3005740500-2013-00005
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 24, 2013
    Manufacturer
    PRESTIGE BRANDS HOLDINGS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K032271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS ORIGINALLY RECEIVED FROM A CONSUMER VIA PHONE ON (B)(6) 2013. THE CONSUMER REPORTS THAT SHE APPLIED THE PRODUCT TO A WART ON HER THIGH ON OR AROUND (B)(6) 2013. SHE ADMITS THAT PRODUCT ACCIDENTALLY GOT ON HEALTHY SURROUNDING SKIN. ABOUT 1 WEEK AFTER USE, THE QUARTER-SIZED AREA BLISTERED, AND HAS BEEN ALTERNATELY PEELING, SCABBING, AND SEEPING. AREA IS PAINFUL AND WARM TO THE TOUCH. SHE HAS BEEN TAKING ORAL ANTIBIOTICS LEFT OVER FROM A PREVIOUS PRESCRIPTION, CLEANING THE AREA DAILY WITH HYDROGEN PEROXIDE, AND APPLYING NEOSPORIN. THE CONSUMER WAS INSTRUCTED TO SEE A PHYSICIAN IMMEDIATELY. FOLLOW-UP WAS COMPLETED WITH THE CONSUMER ON (B)(6) 2013. THE CONSUMER REPORTS THAT AFTER HER INITIAL CALL SHE WAS EVALUATED BY AN MD IN AN EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH 2ND AND 3RD DEGREE BURNS TO THE AREA OF APPLICATION. SHE WAS PRESCRIBED A TOPICAL ANTIBIOTIC AS WELL AS SILVER SULFADIAZINE. THERE MAY BE SOME SCARRING. THE AREA HAS BEEN GRADUALLY IMPROVING AND SHE HAS AN FOLLOW UP APPOINTMENT SCHEDULED WITH HER PHYSICIAN ON (B)(6) 2013. FOLLOW-UP INFORMATION OBTAINED ON (B)(6) 2013, HAS PROMPTED A CLASSIFICATION OF THIS ADVERSE EVENT AS SERIOUS EVENT AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288642 COMPOUND W FREEZE OFF WART REMOVER (DIMETHYL ETHER AND PROPANE) GEH PRESTIGE BRANDS HOLDINGS, INC. USBCFHB1276

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other