BEUDAMED
    FDA Adverse Event Other Summary report: N

    DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER

    MDR report key: 1286776 · Received January 8, 2009

    Report

    Report Number
    1031623-2009-00001
    Event Type
    Other
    Date Received
    January 8, 2009
    Date of Event
    December 10, 2008
    Report Date
    January 8, 2009
    Manufacturer
    SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    A US SPONTANEOUS REPORT WAS RECEIVED FROM A FEMALE CONSUMER, AGE NOT PROVIDED. INITIALS ANONYMIZED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT PROVIDED. A CONSUMER STATED THAT SHE PURCHASED DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER TO USE ON HER SON'S WART ON (B) (6) 2008. SHE REPORTED THAT WHEN SHE TRIED TO FREEZE THE APPLICATOR, THE CAN "EXPLODED" AND "CAUGHT ON FIRE" LAST NIGHT ((B) (6) 2008). SHE STATED THAT SHE HELD DOWN THE APPLICATOR AND IT IGNITED AFTER 2 SECONDS. SHE STATED THAT SHE WAS NOT SMOKING WHEN SHE DID THIS. SHE STATED THAT IT SCARED HER WHEN IT HAPPENED AND SHE THREW THE CAN ACROSS THE ROOM. SHE REPORTED THAT SHE BLEW OUT THE FLAME. SHE STATED THAT IT DID NOT BURN HER, BUT HER ARM WAS RED AND STINGING. SHE STATED THAT IT "SINGED THE HAIR" ON HER ARM A LITTLE. SHE REPORTED THAT THE APPLICATOR TIP AND BLUE CAP WERE ON FIRE AND THE INSIDE OF HER PURSE CAUGHT ON FIRE. SHE STATED THAT HER PURSE WAS RIGHT NEXT TO HER WHEN SHE WAS USING THE PRODUCT. NOTHING ELSE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DR. SCHOLL'S FREEZE AWAY COMMON & PLANTAR WART REMOVER NONE GEH SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. 8G10CC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening