BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLIGRIP

    MDR report key: 3772127 · Received April 10, 2014

    Report

    Report Number
    9681138-2014-00009
    Event Type
    Other
    Date Received
    April 10, 2014
    Date of Event
    November 21, 2012
    Report Date
    April 9, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSOCIATED WITH A PHARMACEUTICAL PRODUCT COMPLAINT. THE MANUFACTURER NUMBER FOR THIS CASE IS (B)(4). POLIGRIP IS MANUFACTURED IN (B)(4) AND THE LOT NUMBER WAS NOT AVAILABLE. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL, VIA A SALES REPRESENTATIVE, AND DESCRIBED THE OCCURRENCE OF ALLERGIC REACTION IN A PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (POLIGRIP) FOR AN UNKNOWN DRUG INDICATION. ON AN UNKNOWN DATE, THE PT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN). AT AN UNKNOWN TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNKNOWN), THE PT EXPERIENCED ALLERGIC REACTION, JAWS WERE SORE, PRURITIC SKIN RASH ON ARM AND UPSET STOMACH. THE PT WAS TREATED WITH ANTIHISTAMINES. AT THE TIME OF REPORTING, THE EVENTS WERE IMPROVED AFTER TWO WEEKS. FOLLOW UP INFORMATION RECEIVED FROM A CONSUMER ON (B)(6) 2014: THE PT WAS A (B)(6) OLD FEMALE WHO USED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) (POLIGRIP) CREAM OVER A PERIOD OF 52 DAYS. CONCURRENT MEDICAL CONDITIONS INCLUDED ASTHMA. CONCURRENT MEDICATIONS INCLUDED SALBUTAMOL SULPHATE (SALBUTAMOL), SALMETEROL XINAFOATE (SEREVENT), IBUPROFEN AND TRAMADOL HYDROCHLORIDE (TRAMADOL). ON (B)(6) 2012 THE PT STARTED GSK DENTURE ADHESIVE (FORMULATION UNKNOWN). ON THE SAME DAY, THE PT EXPERIENCED ALLERGIC REACTION, PRURITIC SKIN RASH ON ARM, UPSET STOMACH AND INDIGESTION. THE PT CONSIDERED THE EVENTS TO BE CLINICALLY SIGNIFICANT (OR REQUIRING INTERVENTION). TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNKNOWN) WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE IMPROVED. THE PT CONSIDERED THE EVENTS OF ALLERGIC REACTION, PRURITIC SKIN RASH ON ARM, UPSET STOMACH AND INDIGESTION WERE RELATED TO TREATMENT WITH GSK DENTURE ADHESIVE (FORMULATION UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216300 POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITHKLINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention IBUPROFEN (UNK - UNK)| TRAMADOL (UNK - UNK)| SALBUTAMOL (UNK - UNK)| SEREVENT (UNK - UNK)