BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS SONICARE

    MDR report key: 8004295 · Received October 25, 2018

    Report

    Report Number
    3026630-2018-00358
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 4, 2018
    Manufacturer
    PHILIPS ORAL HEALTHCARE
    Product Code
    EFS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER EXPERIENCED GINGIVAL INFLAMMATION. COMPLAINT RECEIVED FROM (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL ACCESSORIES RETURNED AND EVALUATED WITH NO DEFECTS OR MALFUNCTIONS FOUND: PART NUMBER: DATE CODE: DESCRIPTION: HX6100; 180521 2B; TRITON BASE CHARGER; HX803X; 180219-02; AIRFLOSS PRO/ULTRA INTERDENTAL NOZZLE (QTY: 2). THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THEY DEVELOPED GINGIVAL INFLAMMATION FROM USING AIRFLOSS. MEDICAL ATTENTION WAS SOUGHT FROM A DENTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844636 PHILIPS SONICARE AIRFLOSS PRO/ULTRA EFS PHILIPS ORAL HEALTHCARE HX8340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other