POLIDENT TABLETS
Received Jan 5, 2005 · Event occurred Jan 1, 1991
Report 1020379-2004-00019 · MDR key 564018
Device
Generic name
Denture Cleanser
Manufacturer
Glaxosmithkline Consumer HealthcareModel number
*Catalog number
*
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
62 YR
- Paralysis
- Stroke
- Visual Disturbances
- Surgical procedure
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF A STROKE IN A PT WHO USED POLIDENT DENTURE CLEANSER TABLETS FOR STAIN DENTURES. THE CONSUMER CALLED WITH A PRODUCT QUESTION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PT'S PAST MEDICAL HISTORY INCLUDED SMOKING. CONCURRENT MEDICAL CONDITIONS INCLUDED ARTERITIS, HEARTBURN AND HIGH BLOOD PRESSURE. CONCURRENT MEDICATIONS INCLUDED CARDIZEM SR, GLYBURIDE, DETROL LA, PEPCID AND CENTRUM SILVER. IN 1945 THE PT STARTED USING POLIDENT DENTURE CLEANSER TABLETS. IN 1991, THE PT EXPERIENCED DOUBLE VISION, LIGHT-HEADEDNESS AND COLLAPSED ACUTELY FALLING DOWN. THEY WERE TAKEN TO THE ER AND DIAGNOSED WITH A STROKE; PT COULD NOT RECALL THE TREATMETNS. AS A CONSEQUENCE THE PT WALKS WITH A CANE AND A WALKER ALTERNATIVELY AND HAS LEFT-SIDED PARALYSIS. DURING THEIR 2 WEEK HOSPITALIZATION THE PT WAS ALSO DIAGNOSED WITH ADULT ONSET DIABETES PT COULD NOT REMEMBER THEIR INITIAL FASTING BLOOD TREATED WITH INSULIN; CURRENTLY THEIR FBS REMAINS STEADY AT 100MG/DL WITH MEDICATION AND PROPER DIET. WHILE IN THE HOSP THE PT ALSO HAD THEIR GALL BLADDER REMOVED DUE TO DETERIORATION AND GALL STONES; PT WAS TREATED WITH POSTOPERATIVE ANALOGESTIC MEDICATIONS. TREATMENT WITH POLIDENT WAS CONTINUED. THE LEFT-SIDED PARALYSIS, DIABETES, CANE AND WHEELCHAIR USE ARE ONGOING; ALL OTHER EVENTS HAVE RESOLVED.