BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPOUND W FREEZE OFF

    MDR report key: 3131480 · Received March 6, 2013

    Report

    Report Number
    1719513-2013-00002
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 28, 2013
    Manufacturer
    PRESTIGE BRAND HOLDINGS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K032271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA PHONE ON (B)(6) 2013. THE CONSUMER REPORTS THAT SHE USED THE PRODUCT ONCE AND SET IT ON HER EMPTY TABLE AND IT THEN BURST INTO FLAMES. SHE DENIES THAT IT WAS EXPOSED TO HEAT OF ANY TYPE. A PREPAID MAILER IS BEING SENT TO THE CONSUMER FOR PRODUCT RETRIEVAL AND TESTING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96643 COMPOUND W FREEZE OFF DIMETHYL ETHER AND PROPANE GEH PRESTIGE BRAND HOLDINGS, INC. US-CCGFB2276

    Patients

    Seq Age Sex Outcome Treatment
    1 Other