BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSONIC CLEANSING AND EXFOLIATION SYSTEM, STANDARD

    MDR report key: 2999525 · Received February 28, 2013

    Report

    Report Number
    MW5029275
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ORA
    Product Code
    GFE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I RECENTLY PURCHASED A PROSONIC CLEANSING AND EXFOLIATING SYSTEM FROM (B)(6) ON (B)(6) 2012. I HAVE USED THE PRODUCT APPROX 4-5/WEEKS. ON (B)(6) 2013, I WAS APPROX 15 SECONDS INTO THE SCRUBBING PROCESS. I WAS HOLDING THE EXFOLIATOR WITH MY LEFT HAND AND WAS SCRUBBING MY LEFT CHEEK BONE AND BAM. THE PRODUCT EXPLODED IN MY HAND. I IMMEDIATELY DROPPED THE PRODUCT AND HAD AN INTENSE RINGING IN MY LEFT EAR THAT LAST FOR APPROX 30 MINUTES. I AM CONTINUING TO HAVE INNER EAR PAIN. UPON INSPECTING THE PRODUCT AT A LATER TIME, I BELIEVE THAT SOMETHING BLEW-UP ON THE INSIDE AND FORCED AN EXPLOSION THAT RUPTURED THE RUBBER EXTERIOR BUTTONS TO CAUSE THE LOUD EXPLOSION. I HAVE RESEARCHED THIS ON-LINE AND HAVE NOTICED SIMILAR COMPLAINTS. I HAVE USED THIS PRODUCT AS INSTRUCTED AND DID NOT HAVE IT FOR A LENGTHY PERIOD OF TIME. I BELIEVE THIS PRODUCT TO HAVE A PATTERN OF THESE EXPLOSIONS. DATES OF USE: (B)(6) 2012 - (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86957 PROSONIC CLEANSING AND EXFOLIATION SYSTEM, STANDARD CLEANSING AND EXFOLIATION SYSTEM GFE ORA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention