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POLIDENT TABLETS

Received Jan 5, 2005 · Event occurred Jan 1, 1991

Report 1020379-2004-00019 · MDR key 564018

Device

Generic name

Denture Cleanser

Model 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.