BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 11096211 · Received December 30, 2020

    Report

    Report Number
    3026630-2020-00080
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    December 2, 2020
    Manufacturer
    PHILIPS ORAL HEALTHCARE, LLC
    Product Code
    EFS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE PRODUCT BRAND NAME FROM "PHILIPS" TO "PHILIPS SONICARE", UPDATE COMMON DEVICE NAME FROM "UNIT, ORAL IRRIGATION" TO "AIRFLOSS". THE CONSUMER'S CONTACT PHONE NUMBER WAS IDENTIFIED AND UPDATED. ANALYSIS RESULTS: FAILURE ANALYSIS OF THE RETURNED PRODUCT (PERFORMED AT PHILIPS ORAL HEALTHCARE) IDENTIFIED THAT THE ROOT CAUSE WAS CUSTOMER ABUSE.

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURIES OR PROPERTY DAMAGE WERE REPORTED. EVENT DATE IS APPROXIMATE. FOREIGN REPORT SOURCE: THE COMPLAINT WAS REPORTED BY A CONSUMER FROM (B)(6).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THEIR AIRFLOSS CAUGHT FIRE. NO SERIOUS INJURIES OR PROPERTY DAMAGE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1563104 PHILIPS SONICARE AIRFLOSS EFS PHILIPS ORAL HEALTHCARE, LLC HX8340

    Patients

    Seq Age Sex Outcome Treatment
    1