BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 11655534 · Received April 13, 2021

    Report

    Report Number
    3026630-2021-10010
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    April 5, 2021
    Manufacturer
    PHILIPS ORAL HEALTHCARE, LLC
    Product Code
    JEQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B5: UPDATED DESCRIBE EVENT OR PROBLEM FROM "THE CONSUMER ALLEGED THAT THEIR DAYTONA POWER TOOTHBRUSH EXPLODED WITH HOT FLAMES CAME OUT AND CAUSED 2ND DEGREE BURNS" TP "THE CONSUMER ALLEGED THAT THEIR PHILIPS ONE POWER TOOTHBRUSH EXPLODED WITH HOT FLAMES CAME OUT AND CAUSED 2ND DEGREE BURNS." D2A: REVISED COMMON DEVICE NAME FROM "DAYTONA POWER TOOTHBRUSH" TO "PHILIPS ONE POWERED TOOTHBRUSH". ANALYSIS RESULTS: PRODUCT WAS NOT RETURNED TO CONFIRM A MALFUNCTION HAS OCCURRED. H3 OTHER TEXT: PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE CONSUMER ALLEGED THAT THEIR PHILIPS ONE POWER TOOTHBRUSH EXPLODED WITH HOT FLAMES CAME OUT AND CAUSED 2ND DEGREE BURNS.

    Additional Manufacturer Narrative · 1

    THE OUTCOME ATTRIBUTED TO 2ND DEGREE BURNS. THE EVENT DATE IS APPROXIMATE. MANUFACTURE DATE NOT PROVIDED OR IDENTIFIABLE.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGED THAT THEIR DAYTONA POWER TOOTHBRUSH EXPLODED WITH HOT FLAMES CAME OUT AND CAUSED 2ND DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552214 PHILIPS SONICARE PHILIPS ONE POWERED TOOTHBRUSH JEQ PHILIPS ORAL HEALTHCARE, LLC HY1200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O