BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP

    MDR report key: 2249785 · Received September 8, 2011

    Report

    Report Number
    9681138-2011-00233
    Event Type
    Other
    Date Received
    September 8, 2011
    Report Date
    September 7, 2011
    Manufacturer
    GLAXOSMITH KLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF IRON DEFICIENCY IN A (B)(6) FEMALE PT WHO RECEIVED GSK DENTURE ADHESIVE (FORMULATION UNK) (SUPER POLIGRIP) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE IN 1966, THE PT STARTED GSK DENTURE ADHESIVE (FORMULATION UNK) (DENTAL). AT AN UNK TIME AFTER STARTING GSK DENTURE ADHESIVE (FORMULATION UNK), THE PT EXPERIENCED IRON DEFICIENCY, COPPER DEFICIENCY, LOSS OF STRENGTH AND ANEMIA. THE PT WAS HOSPITALIZED IN THE 1990'S. THE PT WAS TREATED WITH INTRAVENOUS COPPER SALT (COPPER) AND CYANOCOBALAMIN (B12 INJECTIONS). GSK DENTURE ADHESIVE (FORMULATION UNK) WAS DISCONTINUED IN 1990. AT THE TIME OF REPORTING, THE EVENTS OF ANEMIA, IRON DEFICIENCY AND LOSE OF STRENGTH WERE UNRESOLVED AND THE OUTCOME OF THE COPPER DEFICIENCY WAS UNK. CONSUMER REPORTED THAT SHE STARTED USING SUPER POLIGRIP FROM 1966 TO 1990 AND SHE DISCONTINUED SUPER POLIGRIP AFTER THE ONSET OF THE EVENTS. THE PT SWITCHED TO SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM. THE PT SWITCHED TO FIXODENT ABOUT (B)(6) MONTHS PRIOR TO REPORTING (APPROX (B)(6) 2011). CONSUMER REPORTED THAT NO DOCTOR EVER STATED THAT THE PROBLEMS SHE WAS HAVING WERE CAUSED BY SUPER POLIGRIP BUT A FRIEND RECENTLY ADVISED HER ABOUT SOME PROBLEMS WITH SUPER POLIGRIP SO CONSUMER IS RELATED HER PROBLEMS NOW WITH SUPER POLIGRIP. CONSUMER REPORTED THAT SHE WAS HOSPITALIZED FOR A WEEK IN THE 1990'S BECAUSE SHE DIDN'T HAVE ANY COPPER IN HER BODY. CONSUMER REPORTED THAT SHE HAD TO HAVE COPPER THROUGH AN IV. SHE ALSO REPORTED RECENTLY THAT SHE WAS NO IRON IN HER BODY, HAS NO STRENGTH AND THAT SHE IS ANEMIC. CONSUMER REPORTED THAT THE DOCTOR TOLD HER SHE WAS ANEMIC AND SHE HAD TO HAVE B12 SHOTS, BUT SHE ISN'T ABLE TO PROVIDE ANY TIMEFRAME AS TO WHEN THIS OCCURRED. CONSUMER REPORTED THE B12 SHOTS DIDN'T HELP HER. CONSUMER WASN'T ABLE TO RECALL ANY DATES AS TO WHEN SHE HAD THE B12 SHOTS. CONSUMER REPORTED THAT SHE IS INTERESTED IN SUING THE SUPER POLIGRIP COMPANY AND ASKED IF SHE WOULD HAVE TO APPEAR IN COURT. NO FURTHER INFO WAS PROVIDED. CONSUMER HAD LIMITED INFO AND WASN'T ABLE TO RECALL ANY DATES AS TO WHEN EXPERIENCES BEGAN. CONSUMER REPORTED THE EXPERIENCES OF NO STRENGTH, IRON DEFICIENT AND ANEMIA ARE ONGOING. CONSUMER REPORTED THAT SHE ISN'T SURE IF SHE IS STILL COPPER DEFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER POLIGRIP GSK DENTURE ADHESIVE (FORMULATION UNK) KOL GLAXOSMITH KLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM| FIXODENT