BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILIPS SONICARE

    MDR report key: 2469315 · Received February 16, 2012

    Report

    Report Number
    3026630-2012-00001
    Event Type
    Other
    Date Received
    February 16, 2012
    Date of Event
    January 15, 2012
    Report Date
    February 15, 2012
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, THE PRODUCT WILL NOT BE RETURNED FOR EVAL. CUSTOMER CLAIMS THAT THE DENTIST TOLD HIM TO THROW IT OUT. CONSUMER DID NOT ASK FOR ANY COMPENSATION OR A REPLACEMENT. HOWEVER, A REPLACEMENT UNIT WAS SENT TO THE CONSUMER. CONSUMER DID NOT GIVE ANY FURTHER DETAILS AS TO HOW THEY CUT THEIR LIP OR WHAT PRODUCT HE OWNED. ON (B)(4) 2012, WE ARE ATTEMPTING TO VERIFY IF THERE IS A PRODUCT REGISTERED UNDER THE CONSUMER'S NAME, AS WELL AS REQUESTING THE CONSUMER'S DENTIST'S CONTACT INFO FOR FOLLOW UP.

    Description of Event or Problem · 1

    ON (B)(6) 2012, CUSTOMER CLAIMS THAT WHILE USING A SONICARE TOOTHBRUSH, HE CUT THE INSIDE OF HIS LIP ON A SHARP EDGE. CONSUMER STATED THAT THE BLOOD FROM HIS MOUTH "RUINED" THE UNIT WHICH HE WOULD LIKE REPLACED. CONSUMER ALSO STATED THAT HE WENT TO THE HOSPITAL AND GOT THREE STITCHES ON HIS LIP AND WAS WONDERING IF HE WOULD BE COMPENSATED FOR THE TREATMENT AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS SONICARE UNK JEQ PHILIPS ORAL HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other