BEUDAMED
    FDA Adverse Event Other Summary report: N

    COE-SOFT

    MDR report key: 20098541 · Received August 28, 2024

    Report

    Report Number
    MW5159016
    Event Type
    Other
    Date Received
    August 28, 2024
    Date of Event
    June 3, 2024
    Report Date
    August 22, 2024
    Manufacturer
    GC AMERICA, INC.
    Product Code
    EBI
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD AN ALLERGIC REACTION TO A MEDICATION OF OURS (COE SOFT). THE PATIENT EXPERIENCED A SWOLLEN LIP AND IRRITATION AFTER USE OF THE PRODUCT. THE DOCTOR CALLED TO GET THE INGREDIENTS IN COE SOFT BECAUSE THE PATIENT WENT TO THE ER WITH A SWOLLEN LIP AND IRRITATION OF THE PRODUCT. THE DOCTOR INDICATED THAT THE PATIENT DID NOT EXPERIENCE AN ISSUE UNTIL 3 DAYS AFTERWARDS. THE DOCTOR ADMITTED THAT THEY USED AN EXPIRED PRODUCT. THE PRODUCT EXPIRED IN MARCH 2011. THE DOCTOR INDICATED THAT THE PATIENT WAS DOING WELL AND THAT THE SWELLING WENT DOWN WITH THE USE OF BENADRYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597343 COE-SOFT RESIN, DENTURE, RELINING, REPAIRING, REBASING EBI GC AMERICA, INC. 344011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BENADRYL