BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICARE

    MDR report key: 4360394 · Received December 17, 2014

    Report

    Report Number
    3026630-2014-00038
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    July 18, 2014
    Report Date
    December 16, 2014
    Manufacturer
    PHILIPS ORAL HEALTHCARE, INC.
    Product Code
    JES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11/25/2014 RECEIVED THE UNIT IN USED, BUT CLEAN CONDITION, NO CHARGER BASE PROVIDED. WILL NOT TURN ON AND FIRE. PLACED HANDLE ON CHARGER, BUT UNIT WILL NOT CHARGE. INSPECTION OF INTERNAL COMPONENTS REVEALED A SWOLLEN BATTERY WITH RESIDUE EXITING THE BATTERY AND ENTERING PLUNGER SHAFT AS WELL AS SMALL AMOUNT OF CORROSION ON PLUNGER SPRING. SMELL SIMILAR TO ANTIFREEZE AROUND BATTERY AS WELL AS IN PLUNGER SHAFT, BASE OF PLUNGER WITH RESIDUE AT BASE AND ON PLUNGER SEAL. INSPECTION OF THE DROPLET GENERATOR REVEALED THE CUP VALVE WAS NOT SEATED AND WAS SIDEWAYS IN THE RECESS. MSDS FROM (B)(4) LITHIUM BATTERY HAS INDICATED THAT INGESTION HAZARDS DUE TO OVEREXPOSURE ARE AS FOLLOWS: "INGESTION OF ELECTROLYTE SOLUTION CAUSES TISSUE DAMAGE TO THROAT AREA AND GASTRO/RESPIRATORY TRACT. INGESTION OF COBALT AND COBALT COMPOUNDS ARE CONSIDERED TO BE POSSIBLE HUMAN CARCINOGEN(S)" MSDS PDF SHEET INCLUDED AS ATTACHMENT. AS THE CUSTOMER COMPLAINS ONLY OF TASTE AND SMELL AND NOT SKIN OR THROAT IRRITATION, DO NOT HAVE REASON TO ASSUME THAT THE CUSTOMER HAS BEEN OVEREXPOSED. RECOMMEND HAVING MDR EVAL. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT WAS DUE TO SWOLLEN BATTERY WITH FAILED BATTERY SEAL. ON (B)(4) 2014, AFTER REVIEW OF FAILURE ANALYSIS, IT WAS DETERMINED THAT THE ROOT CAUSE FOUND WAS REPORTABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, CUSTOMER CLAIMS UNIT SMELLED AND TASTED LIKE NAIL POLISH REMOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830114 SONICARE AIRFLOSS EFS JES PHILIPS ORAL HEALTHCARE, INC. HX8140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK