BEUDAMED
    FDA Adverse Event Summary report: N

    EQUATE DENTURE ADHESIVE

    MDR report key: 6050391 · Received October 24, 2016

    Report

    Report Number
    1210513-2016-00013
    Date Received
    October 24, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 21, 2016
    Manufacturer
    SHEFFIELD PHARMACEUTICALS, LLC
    Product Code
    KOT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE PRODUCT MADE HER STOMACH ACHE AND VOMIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703311 EQUATE DENTURE ADHESIVE DENTURE ADHESIVE KOT SHEFFIELD PHARMACEUTICALS, LLC 30061

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR