BEUDAMED
    FDA Adverse Event Other Summary report: N

    RETAINER BRITE CLEANING TABLETS

    MDR report key: 1961605 · Received January 10, 2011

    Report

    Report Number
    1219540-2011-00002
    Event Type
    Other
    Date Received
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    TOWER LABORATORIES LTD.
    Product Code
    JER
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES "SHE FEELS THE RETAINER BRITE IS MAKING HER GUMS SWELL". THE CONSUMER ALSO STATED THAT "SHE DID NOT WANT TO SEEK MEDICAL ATTENTION AND DID NOT WANT TO FILL OUT THE PT/ALLERGY QUESTIONAIRE", SHE JUST WANTED TO RETURN THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETAINER BRITE CLEANING TABLETS EFFERVESCENT DENTURE CLNR JER TOWER LABORATORIES LTD. 00940-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 1 TABLET OID DENTAL