BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUATE PWTB POLARIS II BLK SO

    MDR report key: 8894629 · Received August 14, 2019

    Report

    Report Number
    1825660-2019-00595
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 19, 2019
    Report Date
    August 14, 2019
    Manufacturer
    RANIR LLC
    Product Code
    JEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED THE "PRODUCT EXPLODED LIKE A ROCKET IN HER BATHROOM, THE BATTERY SHOT RIGHT OFF THE TOOTHBRUSH." CONSUMER THREW THE BRUSH AWAY, UNABLE TO RETRIEVE THE PRODUCT. THE END CAP BLEW OFF AND BLEW PAST HER PANTS LEG AND CAME OFF. IT DIDN'T HIT HER. CONSUMER BELIEVES SHE PURCHASED THE TOOTHBRUSH LAST FALL. THE BOTTOM PIECE WAS EMPTY, SHE SAID SHE WAS ABLE TO CONTINUE TO USE IT. "THERE WAS GEL COMING OUT OF INSIDE STICKY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689343 EQUATE PWTB POLARIS II BLK SO TOOTHBRUSH, POWERED JEQ RANIR LLC PWTB POLARIS II BLK SO 2PK

    Patients

    Seq Age Sex Outcome Treatment
    1