BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCHOOL FREEZE VERRUCA & WART REMOVER

    MDR report key: 1357798 · Received March 18, 2007

    Report

    Report Number
    2528909-2007-00001
    Event Type
    Other
    Date Received
    March 18, 2007
    Report Date
    March 16, 2007
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PRODUCT INSTRUCTION INSERT: SCHOLL FREEZE VERRUCA & WART REMOVER: "HOW DOES SCHOLL VERRUCA & WART REMOVER WORK?...FREEZES VERRUCA AND WARTS ON THE SPOT, BY RAPIDLY FREEZING THE CORE OF THE VERRUCA OR WART." INSTRUCTIONS PROVIDE SPECIFIC DIRECTIONS FOR USE, INCLUDING "DO NOT PRESS THE BUTTON WHILE THE APPLICATOR IS IN CONTACT WITH THE SKIN." "DO NOT SPRAY GAS DIRECTLY ON SKIN" AND "ALWAYS USE THE APPLICATOR WHEN APPLYING THE PRODUCT." THE METHOD OF APPLICATION WAS NOT REPORTED BUT IS CRITICAL TO DETERMINE IF THE PRODUCT WAS USED CORRECTLY. THE DESCRIPTION OF "WHOLE BACK OF HAND BLISTERED" IMPLIES THAT THE DIRECTIONS WERE NOT FOLLOWED BECAUSE THE AFFECTED AREA SHOULD NOT BE LARGER THAN THE APPLICATOR TIP. THE RETURNED CANISTER AND APPLICATORS WERE TESTED FOR PERFORMANCE AND TEMPERATURE SPECIFICATIONS. ALL RESULTS MEET SPECIFICATIONS WITH NO UNUSUAL OBSERVATIONS DURING TESTING.

    Description of Event or Problem · 1

    A MOTHER APPLIED SCHOLL FREEZE TO HAND OF DAUGHTER. AFTER 8 SECOND APPLICATION, THE MOTHER STOPPED DUE TO DAUGHTER'S DISCOMFORT. MOTHER TOOK DAUGHTER TO EMERGENCY ROOM AS THE WHOLE BACK OF THE DAUGHTER'S HAND WAS BLISTERING. MEDICAL STAFF DIAGNOSED FREEZE BURN AND DRESS THE INJURY. THE CUSTOMER'S REPORT DOES NOT INCLUDE A DESCRIPTION OF THE APPLICATION METHOD OR ADDITIONAL MEDICAL TREATMENT AFTER THE FIRST EVENT. I AM WRITING CONCERNING ONE OF YOUR PRODUCTS. A SCHOLL FREEZE VERRUCA AND WART REMOVER. I BOUGHT THIS TO REMOVE A WART FROM THE BACK OF MY DAUGHTER'S HAND. I READ AND FOLLOWED THE INSTRUCTIONS TO THE LETTER AND EVEN THOUGH THE LEAFLET STATES NOT TO LEAVE IT ON FOR LONGER THAN 40 SECONDS. I HAD TO STOP AFTER ONLY 8 SECONDS AS MY DAUGHTER STARTED CRYING TELLING ME IT WAS MAKING HER HAND COLD AND GO NUMB. AFTER STOPPING I WAITED ANXIOUSLY FOR THE REDNESS IT SAYS IN YOUR LEAFLET MAY APPEAR TO FADE AWAY, INSTEAD IT BEGAN TO BUBBLE. I DECIDED TO TAKE HER TO SEE THE NURSE AT THE HOSPITAL. BY THE TIME I GOT HER THERE THE WHOLE OF THE BACK OF HER HAND HAD COME UP IN A MASSIVE BLISTER. MY LITTLE GIRL BY NOW WAS IN AGONY. THE HOSPITAL DESCRIBED IT AS A FREEZE BURN AND DRESSED IT ACCORDINGLY. SHE HAD TO GO BACK A NUMBER OF TIMES TO HAVE IT RE-DRESSED. THE BLISTER HAS NOW GONE DOWN, BUT THEY THINK IT IS GOING TO LEAVE A SCAR. THIS HAS BEEN A REALLY BAD EXPERIENCE FOR MY DAUGHTER WHO NOW WILL NOT LET ME PUT SIMPLE OINTMENT ONTO CUTS INCASE IT HURTS HER. I HAVE ALWAYS TRUSTED THE SCHOLL NAME AS MY PARENTS USED YOUR PRODUCTS FOR YEARS. IT WAS THEY SAID A NAME YOU COULD TRUST. THIS PRODUCT HOWEVER EVEN WITH ALL INSTRUCTIONS FOLLOWED, BURNT AND MAYBE SCARED MY DAUGHTER. I WOULD JUST HOPE THAT YOU WILL LOOK INTO IT AND TRY AND STOP IT FROM HAPPENING TO ANOTHER CHILD. THE WART I MAY ADD IS STILL FIRMLY IN PLACE. SO I BURNT MY DAUGHTER FOR NOTHING, FOR THIS I FEEL REALLY GUILTY AND WILL NEVER BE ABLE TO FORGIVE MYSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHOOL FREEZE VERRUCA & WART REMOVER CRYOSURGICAL WART REMOVAL SYSTEM GEH ORASURE TECHNOLOGIES, INC. 5299

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other