inforMED
DeathJER

POLIDENT OVERNIGHT TABLET

Received Dec 13, 2004 · Event occurred Jan 1, 2001

Report 1020379-2004-00015 · MDR key 559881

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

85 YR

  • Cancer, Other
  • Death
  • Other (for use when an appropriate patient code cannot be identified)
  • Treatment with medication(s)
  • Hospitalization required

Narrative

Description of Event or Problem

THIS CASE WAS REPORTED BY A CONSUMER'S SPOUSE AND DESCRIBED THE OCCURRENCE OF PROSTATE CANCER IN A PT WHO USED POLIDENT (POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS) FOR DENTAL CLEANING. THE CONSUMER'S SPOUSE CONTACTED THE MFR REGARDING A PRODUCT QUALITY COMPLAINT. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, ABOUT TEN YEARS AGO, THE PT STARTED USING POLIDENT (DENTAL). IN 2001, THE PT EXPERIENCED DIFFICULTY URINATING AND WAS SUBSEQUENTLY DIAGNOSED WITH PROSTATE CANCER. THE PT WAS TREATED WITH VARIOUS PROSTATE MEDICATIONS (UNSPECIFIED) AND TWO CANCER CHEMOTHERAPY TREATMENTS, WHICH THEY DID NOT TOLERATE WELL. TREATMENT WITH POLIDENT WAS CONTINUED. THE PT DIED IN 2004 DUE TO THE PROSTATE CANCER. AN AUTOPSY WAS NOT PERFORMED.