BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICARE

    MDR report key: 6096344 · Received November 11, 2016

    Report

    Report Number
    3026630-2016-00024
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 20, 2016
    Report Date
    March 3, 2017
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER AGREED TO RETURN THE PRODUCT FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 12:43:39 PM - THE HANDLE ARRIVED IN USED AND DIRTY CONDITION WITH NO CHARGER, OR BRUSH HEAD INCLUDED. THE HANDLE WILL TURN ON, OPERATE AND CHARGE ON THE LAB CHARGER. CUSTOMER HAS ATTEMPTED OPENING DEVICE AS EVIDENCED BY MARKS ON END CAP. CHARGED THE HANDLE FOR 24 HOURS AND IT FAILED THE DEVICE OPERATIONAL TEST DUE TO LOW AMPLITUDE SPECIFICATION. INTERNAL INSPECTION REVEALED A LOOSE BRUSH HUB SCREW. THE EXCESSIVE MOVEMENT CAUSED A SLIGHT TEAR IN THE UPPER SEAL. THERE IS A SLIGHT SLURRY RESIDUE ON THE BRUSH HUB, BUT THERE IS NO OTHER INDICATION OF LIQUID INTRUSION ON THE UPPER DRIVE TRAIN, OR THE PCB. RETESTED THE UNIT FOR AMPLITUDE AND FREQUENCY WITH THE BRUSH HEAD SCREW TIGHTENED AND THE UNIT PASSED OPERATIONAL TEST. ON (B)(6) 2017 12:43:39 PM - THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS LOOSE BRUSH HUB SCREW. THERE IS AN INTERNAL INVESTIGATION INITIATED TO DETERMINE THE CAUSE OF THE BRUSH HUB SCREW COMING LOOSE.

    Description of Event or Problem · 1

    CONSUMER CLAIMS THAT THE STEM OF THE TOOTHBRUSH WAS LOOSE AND WHILE HE WAS BRUSHING HIS TEETH, IT CHIPPED HIS TOOTH.

    Description of Event or Problem · 1

    CONSUMER CLAIMS THAT THE STEM OF THE TOOTHBRUSH WAS LOOSE AND WHILE HE WAS BRUSHING HIS TEETH IT CHIPPED HIS TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747371 SONICARE FLEXCARE JEQ PHILIPS ORAL HEALTHCARE HX6910 091001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other