BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIDENT ADHESIVE MAXIMUM/FRANCE

    MDR report key: 302830 · Received October 30, 2000

    Report

    Report Number
    9681138-2000-00001
    Event Type
    Other
    Date Received
    October 30, 2000
    Date of Event
    October 6, 2000
    Report Date
    October 27, 2000
    Manufacturer
    BLOCK DRUG COMPANY, INC.
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A CONSUMER WHO WAS A FIRST TIME USER OF MAXIMUM POLIDENT DENTURE ADHESIVE CREAM APPLIED THE ADHESIVE ONCE DAILY FOR 2 DAYS AND ON THE FIRST DAY OF PRODUCT USE PT EXPERIENCED "LIGHT PRURITUS" ON THEIR BODY ALONG WITH A SKIN ERUPTION (SKIN RASH). WITH SYMPTOMS ONGOING, THE CONSUMER USED THE PRODUCT ON THE SECOND DAY AND THAT NIGHT EXPERIENCED RED PLAQUES ON THEIR WHOLE BODY ALONG WITH SWELLING OF THE LIPS, MOUTH AND FACE. THE CONSUMER WAS ALSO EXPERIENCING DIFFICULTY SWALLOWING AND SPEAKING; IS NOT KNOWN IF THE CONSUMER EXPERIENCED DIFFICULTY BREATHING. THE NEXT DAY THE CONSUMER WAS ADMITTED TO THE HOSP AND TREATED WITH AN UNKNOWN ANTI-ALLERGIC MEDICATION. THE CONSUMER WAS HOSPITALIZED FOR A TOTAL OF 2 DAYS. BASED ON THE REPORT, IT IS BELIEVED THAT ALL OF THE CONSUMER'S SYMPTOMS HAVE RESOLVED. THE CONSUMER REPORTED THAT THEY HAD USED POLIDENT ADHESIVE CREAM (SODIUM/CALCIUM GANTREZ SALT AND CARBOXYMETHYLCELLULOSE) FOR SEVERAL YEARS WITHOUT INCIDENT. AT THIS TIME OF THE REPORT, NO ADDITIONAL INFORMATION IS AVAILABLE, HOWEVER, ADDITIONAL FOLLOW-UP WITH THE TREATING PHYSICIAN IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIDENT ADHESIVE MAXIMUM/FRANCE DENTURE ADHESIVE KOO BLOCK DRUG COMPANY, INC. * X00155

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization