BEUDAMED
    FDA Adverse Event Summary report: N

    EQUATE DENTURE ADHESIVE

    MDR report key: 5897694 · Received August 23, 2016

    Report

    Report Number
    1210513-2016-00012
    Date Received
    August 23, 2016
    Date of Event
    August 6, 2016
    Report Date
    August 23, 2016
    Manufacturer
    SHEFFIELD PHARMACEUTICALS, LLC
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) USED THE EQUATE DENTURE ADHESIVE CREAM AND IT CAUSED HER TO THROW UP, HAVE NAUSEA AND HER MOUTH TO SWELL. SHE WAS GOING TO SEEK MEDICAL ATTENTION. REPEATED ATTEMPTS TO REACH HER HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550152 EQUATE DENTURE ADHESIVE DENTURE ADHESIVE KOO SHEFFIELD PHARMACEUTICALS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR