BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE DENTURE ADHESIVE

    MDR report key: 4173289 · Received September 26, 2014

    Report

    Report Number
    1210513-2014-00002
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    October 31, 2013
    Report Date
    September 17, 2014
    Manufacturer
    SHEFFIELD PHARMACEUTICALS
    Product Code
    KOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESERVE SAMPLE (30711) WITH THE SAME LOT AS THE SUSPECT SAMPLE WAS TESTED FOR TOTAL AEROBIC PLATE COUNT AND ATTRIBUTES. NO ISSUES WERE IDENTIFIED WITH THE TEST RESULTS.

    Description of Event or Problem · 1

    THE PT/REPORTER CLAIMED THAT EQUATE DENTURE ADHESIVE, AFTER SHE USED IT FOR THE FIRST TIME, MADE HER NAUSEATED AND VOMIT. IN ADDITION, THE PRODUCT ALSO HAD A BAD SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600115 EQUATE DENTURE ADHESIVE DENTURE ADHESIVE KOQ SHEFFIELD PHARMACEUTICALS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other