BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER POLIGRIP COMFORT SEAL STRIPS

    MDR report key: 3150095 · Received June 3, 2013

    Report

    Report Number
    3004699328-2013-00001
    Event Type
    Other
    Date Received
    June 3, 2013
    Report Date
    May 31, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPER POLIGRIP COMFORT SEAL STRIPS ARE MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF INTESTINAL OBSTRUCTION IN A (B)(6) FEMALE PT WHO USED POLYETHYLENE OXIDE AND SODIUM CARBOXYMETHYLCELLULOSE (SUPER POLIGRIP COMFORT SEAL STRIPS) STRIP FOR DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED CROHN'S DISEASE. CONCURRENT MEDICATIONS INCLUDED AZATHIOPRINE (IMURAN), TRIAMTERENE AND HYDROCHLOROTHIAZIDE (DYAZIDE), PREDNISONE, VICODIN, HYDROMORPHONE HYDROCHLORIDE (DILAUDID), AND OMEPRAZOLE (PRILOSEC). ON AN UNK DATE, THE PT USED SUPER POLIGRIP COMFORT SEAL STRIPS (DENTAL) AT UNK DOSING. AT AN UNK TIME AFTER USING SUPER POLIGRIP COMFORT SEAL STRIPS, THE PT EXPERIENCED INTESTINAL OBSTRUCTION, ABDOMINAL OPERATION, PASSED OUT, ABDOMINAL SWELLING, ABDOMINAL PAIN, VOMITING, WEAKNESS, WEIGHT LOSS, PAIN, AND DRUG MALADMINISTRATION. THE PT WAS HOSPITALIZED. TREATMENT WITH SUPER POLIGRIP COMFORT SEAL STRIPS WAS DISCONTINUED. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. REPORT REC'D (B)(6) 2013: CONSUMER REPORTED THAT SHE HAD ABDOMINAL SURGERY IN (B)(6) 2013 BECAUSE SHE WAS HAVING BOWEL OBSTRUCTIONS FROM WHAT THEY HAD THOUGHT AT THE TIME WAS CAUSED BY SCAR TISSUE FROM A PAST SURGERY IN 1990. SHE REPORTED THAT SINCE SHE HAD HER ABDOMINAL SURGERY SHE HAS HAD SIX BOWEL OBSTRUCTIONS. SHE STATED ONE BOWEL OBSTRUCTION HAPPENED TWO DAYS AFTER HER SURGERY WHICH THEY THOUGH WAS FROM THE SURGERY BECAUSE SHE HAD SWELLING. SHE STATED THAT SHE WENT TO TAKE HER DENTURE OUT AND THERE WAS NO STRIP. SHE REPORTED THAT A WEEK LATER SHE HAD ANOTHER BOWEL OBSTRUCTION AND NO STRIPS WERE PRESENT WHEN SHE WENT TO REMOVE HER DENTURE THEN EITHER. SHE STATED THAT SHE HAS SWALLOWED THE STRIPS (DRUG MALADMINISTRATION) THREE TIMES SINCE FEBRUARY. SHE STOPPED USING THE PRODUCT AFTER HER DENTIST HAD ADVISED HER THAT THE STRIPS TO DO NOT PASS THROUGH YOUR BOWELS AND THAT THEY ADHERE TO THE BOWELS. THE CONSUMER DESCRIBED THAT WITH HER BOWEL OBSTRUCTIONS SHE WOULD GO THROUGH SIX TO EIGHT HRS OF PAIN AND THEN VOMITING. SHE STATED THERE WOULD BE A SNAP THEN THE PAIN WOULD SUBSIDE AND HER BOWELS WOULD MOVE. SHE STATED THAT SHE WOULD THEN BE WEAK FOR TWO DAYS FROM WHAT SHE HAD TO GO THROUGH. CONSUMER REPORTED THAT SINCE HER SURGERY, SHE HAS LOST A LOT OF WEIGHT. CONSUMER REPORTED THAT HER LAST BOWEL OBSTRUCTION WAS (B)(6) 2013. SHE STATED THAT THE PAIN WAS SO BAD THAT SHE PASSED OUT AND WHEN SHE WOKE UP IN THE MORNING IN HER BED SHE WAS FINE. THE CONSUMER BELIEVES THAT DIGESTING THE SUPER POLIGRIP STRIPS HAVE CAUSED HER PROBLEMS. THE CONSUMER REPORTED THAT SHE HAD A CAT SCAN TODAY AND IS WAITING TO FIND OUT THE RESULTS TO SEE IF THERE IS ADHESIVE IN HER BOWELS. SHE STATED THAT HER GASTROENTEROLOGIST TOLD HER THAT HE REMOVED A BIG BALL OF DENTURE ADHESIVE FROM ONE OF HIS PT'S BOWELS. CONSUMER THREATENED SHE BETTER SEE A WARNING LABEL ON THE BOX FOR INDIVIDUALS WHO HAVE BOWEL PROBLEMS WITHIN THE NEXT COUPLE MONTHS OR SHE WILL HAVE A LAWSUIT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242744 SUPER POLIGRIP COMFORT SEAL STRIPS POLYETHYLENE OXIDE+SODIUM CARBOXYMETHYL KOO GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization DILAUDID| PREDNISONE| VICODIN| IMURAN| PRILOSEC| DYAZIDE