BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORAL B FLEXISOFT

    MDR report key: 4163209 · Received October 7, 2014

    Report

    Report Number
    MW5038546
    Event Type
    Other
    Date Received
    October 7, 2014
    Date of Event
    June 7, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BRAUN
    Product Code
    EFW
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATED THAT THE TOOTHBRUSH HEAD HAS A TINY PIECE OF METAL AND PLASTIC THAT DETACHES WHILE IN USE, WHICH CAN CAUSE A CHOKING HAZARD FOR THE CONSUMER. THIS INCIDENT OCCURRED AFTER USING THE TOOTHBRUSH APPROXIMATELY 10-15 TIMES. ON (B)(6) 2014 THE MANUFACTURER WAS CONTACTED AND HE WAS SENT A REPLACEMENT, HE WAS ADVISED TO KEEP THE PRODUCT FOR A FEW WEEKS BUT IF HE DID NOT HEAR FROM THEM TO DISCARD IT. CALLER STATED THAT HE KEPT THE PRODUCT TO REPORT IT DUE TO THE SAFETY HAZARD IT POSES. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: 20141001-C1296-1431726.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629949 ORAL B FLEXISOFT TOOTHBRUSH BRISTLE EFW BRAUN EB17-4+1

    Patients

    Seq Age Sex Outcome Treatment
    1