BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER PLOIGRIP FREE DENTURE ADHESIVE CREAM

    MDR report key: 4073009 · Received September 2, 2014

    Report

    Report Number
    9681138-2014-00019
    Event Type
    Other
    Date Received
    September 2, 2014
    Report Date
    August 28, 2014
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S REPORT NUMBER FOR THIS CASE IS 9681138-2014-00019. SUPER POLIGRIP IS MANUFACTURED IN (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER, IT IS UNK WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF RENAL INJURY IN A (B)(6) OLD MALE PT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGIRP FREE DENTURE ADHESIVE CREAM) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTHCARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED DOUBLE SALT DENTAL ADHESIVE CREAM. AT AN UNK TIME AFTER STARTING DOUBLE SALT DENTAL ADHESIVE CREAM, THE PT EXPERIENCED RENAL INJURY. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH DOUBLE SALT DENTAL ADHESIVE CREAM WAS CONTINUED. AT THE TIME OF REPORTING, THE EVENT WAS UNRESOLVED. CONSUMER REPORTED THAT HE HAS USED SUPER POLIGRIP FREE FOR A LONG TIME. CONSUMER STATED THAT (B)(6) 2014 HIS DOCTOR TOLD HIM HE HAS CHRONIC KIDNEY DAMAGE. CONSUMER IS STILL EXPERIENCING THIS EVENT AND IS CONTINUING TO USE THE PRODUCT. CUSTOMER REPORTED THAT HE HAD AN ULTRASOUND ON (B)(6) 2014. THE PT DID NOT PROVIDE CONTACT INFO AS HE DID NOT WISH TO BE CONTACTED; THEREFORE, THIS CASE IS LOST TO FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532336 SUPER PLOIGRIP FREE DENTURE ADHESIVE CREAM DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA P14104A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other LUTEIN| ZINC| GARLIC