BEUDAMED
    FDA Adverse Event Summary report: N

    POLIGRIP

    MDR report key: 27388 · Received October 11, 1995

    Report

    Report Number
    MW4000932
    Date Received
    October 11, 1995
    Report Date
    April 27, 1995
    Manufacturer
    DENTCO, INC.
    Product Code
    KOP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT PURCHASED DENTURE ADHESIVE IN 5/94. SHE HAD BEEN WEARING A PARTIAL PLATE FOR ABOUT 10 YRS. THE PLATE BROKE, & WHILE SHE WAS WAITING FOR IT TO BE REPAIRED, SHE USED THE ADHESIVE TO HOLD HER DENTURES IN PLACE. SHE BEGAN EXPERIENCING SHORTNESS OF BREATH, LIGHT-HEADEDNESS, FEELING OF FAINTNESS, SURGERY FOR A DEVIATED SEPTUM IN 12/94. SHE SAID SHE HAD BEEN TO MORE THAN ONE DR TRYING TO RESOLVE HER PROBLEM, & SHE HAS ENDURED MUCH PAIN & SUFFERING. SHE HAS BEEN UNABLE TO WORK FOR ABOUT A YR & HAS INCURRED $10,000 IN MED BILLS. SHE SAID SHE KNEW SHE WAS ALLERGIC TO SULFUR, BUT THE ADHESIVE'S LABEL DID NOT SHOW IT CONTAINED SULFUR. WHEN SHE DISCONTINUED USING THE PRODUCT, HER PROBLEMS DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLIGRIP DENTURE ADHESIVE CREAM KOP DENTCO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *