inforMED
OtherJER

POLIDENT (UNKNOWN)

Received Jun 14, 2005

Report 1020379-2005-00006 · MDR key 614101

Device

Generic name

Dental Cleanser

Model number

*

Catalog number

*

Lot number

UNK

Product problems

  • Unknown (for use when the device problem is not known)

Patient

*

  • Allergic reaction
  • Atrial Fibrillation
  • Erythema
  • Itching Sensation
  • Swelling
  • Reaction
  • Treatment with medication(s)

Narrative

Description of Event or Problem

CONSUMER REPORTED USING UNSPECIFIED POLIDENT ON THEIR DENTURES AND HAD A REACTION. THEY DESCRIBED THE REACTION AS AN ALLERGIC REACTION. THEY DESCRIBED THE REACTION AS ITCHING OF THE FACE. THEY ALSO WENT INTO "AFIB" WHICH WAS DESCRIBED AS AN IRREGULAR HEARTBEAT. THEY HAVE HAD A SIMILAR REACTIONS TO DENTURE PRODUCTS IN THE PAST AND THE FIRST TIME THEY WERE TREATED BY "SHOCKING THEIR HEART TWICE" AND ORAL MEDICATIONS, COUMADIN 2.5 MG DAILY AND TOPROL XL 25MG DAILY. THEY CONTINUED THE USE OF THE MEDICATIONS AND THEY RECOVERED FROM THE EVENTS.