BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 5903658 · Received August 23, 2016

    Report

    Report Number
    MW5064334
    Event Type
    Injury
    Date Received
    August 23, 2016
    Date of Event
    August 3, 2016
    Manufacturer
    PHILIPS ORAL HEALTHCARE, INC.
    Product Code
    JEQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PHILIPS SONICARE ELECTRIC TOOTHBRUSH S/N (B)(4) AKA MODEL HX 6711 AND HX 6710 INTERMITTENTLY ACTIVATES (I.E., TURNS ITSELF ON) WITHOUT THE USER TOUCHING IT WHETHER THE UNIT IS LEFT ON ITS CHARGING BASE OR STANDING DIRECTLY ON COUNTER OR TABLE. UNIT SELF-ACTIVATED TWICE ON (B)(6) 2016, THREE TIMES ON (B)(6) 2016 AND ONCE ON (B)(6) 2016. FOLLOWING THE LAST INCIDENT ON (B)(6) 2016, THE UNIT'S INTERNAL LITHIUM-ION BATTERY BECAME DISCHARGED. USER SPOKE WITH (B)(6) AT PHILIPS SONICARE ON (B)(6) 2016 TO REPORT INCIDENTS OF (B)(6) 2016. (B)(6) RESPONDED THAT PHILIPS CONICARE HAS RECEIVED SIMILAR REPORTS BUT OFFERED NO ASSISTANCE OR INTEREST IN RETRIEVING THE DEFECTIVE PRODUCT FOR EVALUATION. USER CONTENDS THAT PRODUCT IS DEFECTIVE AND HAS POTENTIAL OF CAUSING INJURY OR HARM DUE TO UNATTENDED OPERATION OF DEVICE WITH LITHIUM-ION BATTERY. WHEN THE DEVICE SELF-ACTIVATES, THE VIBRATION OF THE UNIT CAUSES IT TO MOVE AROUND THE COUNTER OR TABLE AND HAS A HIGH POTENTIAL OF FALLING TO THE FLOOR, RESULTING IN RISK OF RUPTURE TO THE UNIT AND ITS INTERNAL LITHIUM-ION BATTERY. USER SUSPECTS THAT A SEAL ON THE UNIT IS DEFECTIVE, ALLOWING WATER TO PENETRATE UNIT AND SHORT THE ON-OFF SWITCH. PRODUCT DESCRIPTION: PHILIPS SONICARE ELECTRIC TOOTHBRUSH MODEL HX6711/02 AND/OR HX6710. RETAILER: (B)(6). RETAILER STATE: (B)(6). PURCHASE DATE: 02/17/2011. I STILL HAVE THE PRODUCT IN MY POSSESSION: YES. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. EXPLANATION: ON (B)(6) 2016M (B)(6) AT PHILIPS SONICARE ACKNOWLEDGED PRIOR REPORTS OF SIMILAR NATURE FROM OTHER CONSUMERS. NO FURTHER ACTION WAS ADVISED BY (B)(6). MAY WE INCLUDE YOUR REPORT: YES, YOU MAY INCLUDE MY REPORT WITH ANY ATTACHMENTS ON SAFERPRODUCTS.GOV. MAY WE RELEASE YOUR NAME AND CONTACT INFORMATION TO THE PRODUCT MANUFACTURER/IMPORTER/PRIVATE LABELER IDENTIFIED IN YOUR REPORT: NO, DO NOT RELEASE MY NAME AND CONTACT TO THE PRODUCT MANUFACTURER/IMPORTER/PRIVATE LABELER. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550888 PHILIPS SONICARE PHILIPS SONICARE JEQ PHILIPS ORAL HEALTHCARE, INC. HX6711/02 HEALTHY WHITE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR