BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 3649871 · Received February 6, 2014

    Report

    Report Number
    3005740500-2014-00002
    Event Type
    Injury
    Date Received
    February 6, 2014
    Date of Event
    January 17, 2014
    Report Date
    February 6, 2014
    Manufacturer
    PRESTIGE BRANDS HOLDINGS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K032271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MOTHER REPORTED THEIR (B)(6) SON EXPERIENCING THIRD DEGREE BURNS WHILE USING COMPOUND W FREEZE OFF WART REMOVAL SYSTEM. THE CONSUMER REPORTED THEY STARTED USING COMPOUND W FREEZE OFF WART REMOVAL SYSTEM ON FRIDAY, (B)(6) 2014. AFTER USE OF THE PRODUCT, THE BOY DEVELOPED APPLICATION SITE BURNS. THE REPORTER STATED THE CHILD SCREAMED ALMOST IMMEDIATELY AFTER THE PRODUCT WAS APPLIED TO A WART ON HIS HAND, SO SHE PROMPTLY DISCONTINUED TREATMENT. SHE STATED THE BOY DEVELOPED A BUBBLE AT THE APPLICATION SITE. THE CHILD WAS BEING TREATED IN THE EMERGENCY ROOM FOR THE FLU A FEW DAYS LATER WHEN THE PHYSICIAN NOTICED THE BUBBLE ON THE CHILD'S AND STATED IT WAS A THIRD DEGREE BURN. AS OF (B)(6) 2014, THERE IS A QUARTER-SIZED RED RING ON THE CHILD'S HAND WHICH THE PHYSICIAN INFORMED HER WILL BE REPLACED BY A SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78373 COMPOUND W FREEZE OFF WART REMOVER (DIMETHYLETHER AND PROPANE) GEH PRESTIGE BRANDS HOLDINGS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other