BEUDAMED
    FDA Adverse Event Summary report: N

    EQUATE SUPER HOLD DENTURE ADHSEIVE

    MDR report key: 6128787 · Received November 28, 2016

    Report

    Report Number
    1210513-2016-00014
    Date Received
    November 28, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 28, 2016
    Manufacturer
    SHEFFIELD PHARMACEUTICALS, LLC
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER USE OF THE PRODUCT, PATIENT CLAIMED HIS LIPS SWELLED. NO MEDICAL ATTENTION SOUGHT. PROBLEM WENT AWAY AFTER STOPPING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780407 EQUATE SUPER HOLD DENTURE ADHSEIVE DENTURE ADHESIVE KOO SHEFFIELD PHARMACEUTICALS, LLC 60261

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR