BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP (ORIGINAL & EXTRA CARE)

    MDR report key: 1622161 · Received March 1, 2010

    Report

    Report Number
    9681138-2010-00068
    Event Type
    Other
    Date Received
    March 1, 2010
    Report Date
    March 1, 2010
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM AND SUPER POLIGRIP EXTRA CARE WITH POLISEAL ARE MFG IN (B)(4). THE LOT NUMBER FOR SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM IS AVAILABLE (R082538) WHILE THE LOT NUMBER FOR SUPER POLIGRIP EXTRA CARE WITH POLISEAL IS UNK. IT IS UNK WHETHER THE PRODUCTS 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 PASSED OUT IN A (B)(6) FEMALE PT WHO RECEIVED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM (FORMULATION NUMBER (B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTHCARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CO-SUSPECT MEDICATION INCLUDED SUPER POLIGRIP EXTRA CARE WITH POLISEAL (FORMULATION NUMBER (B)(4)). ON AN UNK DATE, THE PT STARTED THE FORMULATIONS OF SUPER POLIGRIP DENTURE ADHESIVE CREAM (DENTAL). AT AN UNK TIME AFTER STARTING SUPER POLIGRIP DENTURE ADHESIVE CREAM, THE PT EXPERIENCED PASSED OUT, WEAKNESS AND NO ENERGY. TREATMENT WITH SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. F/U INFO FROM THE PT WAS RECEIVED ON 24 FEB 2010. THE PT'S PAST MEDICAL HISTORY INCLUDED GUM SURGERY. THE PT REPORTED THAT SHE HAD USED SOME FORM OF SUPER POLIGRIP FOR FIVE TO SIX YRS. THE PT REPORTED THAT SHE HAD BEEN PASSING OUT, FEELING WEAK AND NO ENERGY FOR APPROXIMATELY ONE YR PRIOR TO BEING HOSPITALIZED FOR KNEE SURGERY ON (B)(6) 2009. THE PT REPORTED THAT WHILE HOSPITALIZED, SHE EXPERIENCED PASSING OUT THREE TIMES. SHE STATED THAT HER PHYSICIAN TOLD HER THAT SHE WAS UNRESPONSIVE. THE PT REPORTED THAT SHE WAS DISCHARGED TO HOME BUT DID NOT HAVE A DIAGNOSIS RELATING TO PASSING OUT. DIAGNOSTIC TESTING INCLUDED COMPUTERIZED TOMOGRAM (CT), MAGNETIC RESONANCE IMAGING OF THE BRAIN (MRI), A "24 HR HEART MONITOR" (CARDIAC MONITORING) AND A TILT TEST ALL WHICH REPORTED NEGATIVE. THE PT ALSO REPORTED THAT SHE RELATED PASSING OUT TO WHEN SHE WOULD GO THE BATHROOM AND REAPPLY THE SUPER POLIGRIP SO SHE COULD EAT HER LUNCH. THE PT REPORTED THAT SHE NEEDED TO REAPPLY THE PRODUCT DUE TO GUM RESTORATION (DEVICE MISUSE). TREATMENT WITH SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP (ORIGINAL & EXTRA CARE) DENTURE ADHESIVE (CREAM & GEL) KOL GLAXOSMITHKLINE R082538

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O ASPIRIN| OMEPRAZOLE (PRILOSEC)| PAIN MEDICATIONS| D WARFARIN SODIUM (COUMADIN)