BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE DENTURE ADHESIVE

    MDR report key: 8400125 · Received March 7, 2019

    Report

    Report Number
    1210513-2018-00183
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    December 27, 2018
    Report Date
    December 27, 2018
    Manufacturer
    SHEFFIELD PHARMACEUTICALS LLC
    Product Code
    KOO
    UDI-DI
    68113105300
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT STATED THAT HE WAS HOSPITALIZED WITH STOMACH PROBLEMS SINCE USING THE EQ DENTURE ADHESIVE. CUSTOMER SAID THAT HE HAS HAD A PROBLEM WITH HIS STOMACH FROM WHEN HE FIRST STARTED USING DENTURES BUT NEVER HAD TO GO TO THE HOSPITAL. CUSTOMER WAS NOT ABLE TO SUPPLY THE LOT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194848 EQUATE DENTURE ADHESIVE ADHESIVE, DENTURE KOO SHEFFIELD PHARMACEUTICALS LLC 5502C 80481 68113105300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization