EFFERDENT PLUS W/ FRESHBURST LISTERINE
Received Mar 1, 2005 · Event occurred Jan 31, 2005
Report 2246407-2005-00003 · MDR key 576973
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
78 YR
- Death
- Pneumonia
- Hospitalization required
Narrative
Description of Event or Problem
INVESTIGATION SUMMARY RECEIVED ON 5/2/2005 FROM PFIZER'S QUALITY OPERATIONS/PRODUCT COMPLAINTS GROUP: "A REVIEW OF THE LOT RECORDS FOUND NO DEVIATIONS THAT COULD BE ASSOCIATED WITH THE REPORTED COMPLAINT. RELEASE TESTING PERFORMED FOUND THE LOT MET ALL SPECIFICATIONS FOR DESCRIPTION: DISINTEGRATION TIME, PH, FADE TIME, AND AVAILABLE OXYGEN. ANALYTICAL TESTING OF RETAIN SAMPLES OF THE REPORTED LOT FOUND THE LOT MET ALL SPECIFICATIONS FOR DESCRIPTION, DISINTEGRATION TIME, PH, FADE TIME, AND AVAILABLE OXYGEN. THIS IS THE FIRST COMPLAINT REGISTERED ON THIS LOT SINCE THE DATE OF RELEASE. NO FURTHER INVESTIGATION CAN BE COMPLETED AT THIS TIME."
Description of Event or Problem
A CONSUMER REPORTS THAT THEIR SPOUSE USED ONE TABLET OF EFFERDENT PLUS DENTURE CLEANSER WITH FRESH BURST LISTERINE (SODIUM PERBORATE MONOHYDRATE, POTASSIUM MONOPERSULFATE) ONE PER WEEK BEGINNING IN APPROXIMATELY IN 1995 (EXACT DATE UNSPECIFIED) TO CLEAN THEIR DENTURES. BEGINNING IN 2005, PT HAD PNEUMONIA AND WAS HOSPITALIZED. WHILE IN THE HOSPITAL, PT HAD UNSPECIFIED LABORATORY TESTS (RESULTS UNKNOWN). THE CONSUMER'S SPOUSE DIED FORM AN UNSPECIFIED CAUSE ON AN UNKNOWN DATE IN FEB 2005.