BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLIDENT DENTURE ADHESIVE CREAM

    MDR report key: 4679625 · Received March 10, 2015

    Report

    Report Number
    9681138-2015-00008
    Event Type
    Injury
    Date Received
    March 10, 2015
    Report Date
    February 20, 2015
    Manufacturer
    GSK DUNGARVAN STAFFORD MILLER
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED TO MANUFACTURER NUMBER 1020379-2015-00007 AS POLIDENT DENTURE CLEANSER. UPON FOLLOW-UP, THE SUSPECT PRODUCT WAS DETERMINED TO POLIDENT ADHESIVE CREAM. THUS, ALL FUTURE FOLLOW-UP INFORMATION WILL BE SUBMITTED TO MANUFACTURER NUMBER 9681138-2015-00008.

    Description of Event or Problem · 1

    ASTHAM CRISIS (ASTHMATIC CRISIS). CASE DESCRIPTION: THIS CASE WAS REPORTED BY A DENTIST VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ASTHMATIC CRISIS IN A (B)(6) MALE PATIENT WHO RECEIVED POLIDENT (POLIDENT (UNK) UNKNOWN FOR DENTAL CARE. ON AN UNKNOWN DATE, THE PATIENT STARTED POLIDENT (UNK). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT (UNK), THE PATIENT EXPERIENCED ASTHMATIC CRISIS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE ASTHMATIC CRISIS WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ASTHMATIC CRISIS TO BE RELATED TO POLIDENT (UNK). FOLLOW-UP INFORMATION WAS RECEIVED ON 27 FEBRUARY 2015. THE REPORTER CONFIRMED THAT THE PRODUCT SHE PRESCRIBED WAS AN UNSPECIFIED POLIDENT ADHESIVE CREAM (NOT THE CLEANSER) AND THE SUSPECT PRODUCT WAS UPDATED TO POLIDENT ADHESIVE CREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166049 POLIDENT DENTURE ADHESIVE CREAM DENTURE ADHESIVE KOL GSK DUNGARVAN STAFFORD MILLER

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other