BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICARE

    MDR report key: 4987809 · Received August 5, 2015

    Report

    Report Number
    3026630-2015-00037
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 5, 2015
    Manufacturer
    PHILIPS ORAL HEALTHCARE, INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    JULY 27, 2015. CONSUMER RETURNED THE UNIT FOR EVAL, FAILURE ANALYSIS REPORT PENDING. ANALYSIS RESULTS: 08/07/2015, THE HANDLE ARRIVED IN USED BUT GOOD CONDITION WITH CHARGER AND BRUSH HEAD INCLUDED. THE HANDLE WILL TURN ON, OPERATE AND CHARGE ON THE PROVIDED CHARGER. THE UNIT FAILED THE TRITON QBE TEST. INTERNAL INSPECTION REVEALED LIKE NEW COMPONENTS AND A BATTERY VOLTAGE OF 3.755V. THE INSPECTION OF THE DRIVE-TRAIN REVEALED A LOOSE UPPER BRUSH HEAD SCREW. ROOT CAUSE: (B)(6) 2015, THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS LOOSE UPPER BRUSH HEAD SCREW.

    Additional Manufacturer Narrative · 1

    ON 07/27/2015 CONSUMER RETURNED THE UNIT FOR EVALUATION, FAILURE ANALYSIS REPORT PENDING.

    Description of Event or Problem · 1

    ON (B)(6) 2015, CONSUMER CLAIMS THAT THE UNIT STRIPPED THE ENAMEL OFF OF THEIR TEETH.

    Description of Event or Problem · 1

    ON (B)(6) 2015 CONSUMER CLAIMS THAT THE UNIT STRIPPED THE ENAMEL OFF THEIR TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519199 SONICARE BLACK DIAMONDCLEAN JEQ PHILIPS ORAL HEALTHCARE, INC. HX9350

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other