BEUDAMED
    FDA Adverse Event Other Summary report: N

    RETAINER BRITE

    MDR report key: 3230066 · Received July 11, 2013

    Report

    Report Number
    1219540-2013-00004
    Event Type
    Other
    Date Received
    July 11, 2013
    Date of Event
    May 12, 2013
    Report Date
    July 11, 2013
    Manufacturer
    TOWER LABORATORIES LTD.
    Product Code
    EFT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED HAVING RECEIVED "RETAINER BRITE" SAMPLES FROM HER DENTIST AND ON (B)(6) 2013 USED A SAMPLE. SHORTLY AFTER CLEANING HER DENTAL APPLIANCE, HER MOUTH STARTED BURNING AND ITCHING. CONSUMER DID NOT SEEK MEDICAL TREATMENT, HOWEVER, DID SEE HER DENTIST WITHIN 48 HOURS OF SYMPTOMS AND WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320779 RETAINER BRITE EFFERVESCENT DENTURE CLNR EFT TOWER LABORATORIES LTD. 30237-7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other