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POLIGRIP CREAM

Received Oct 1, 2004 · Event occurred Aug 8, 2004

Report 9681138-2004-00019 · MDR key 543429

Device

Generic name

Denture Adhesive

Manufacturer

Glaxosmithkline

Model number

*

Catalog number

*

Lot number

X04093

Product problems

  • Use of Device Problem

Patient

76 YR

  • Therapy/non-surgical treatment, aborted/stopped
  • Treatment with medication(s)

Narrative

Description of Event or Problem

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF STRESS INCONTINENCE FROM COUGH IN A PT WHO RECEIVED POLIGRIP (SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM) OVER A PERIOD OF TWO DAYS FOR LOOSE DENTURES. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. THE PT'S PAST MEDICAL HISTORY INCLUDED HIGH BLOOD PRESSURE. CONCURRENT MEDICATIONS INCLUDED PREMARIN, HYZAAR AND ANOTHER HIGH BLOOD PRESSURE PILL. IN 2004 THE PT STARTED POLIGRIP (DENTAL). THE PT EXPERIENCED A VIOLENT COUGH, A CHOKING SENSATION AND SUBSEQUENTLY EXPERIENCED STRESS INCONTINENCE FROM THE COUGH. ADDITIONALLY, THE PT EXPERIENCED FULLNESS IN THEIR HEAD. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIGRIP WAS DISCONTINUED. THE EVENTS RESOLVED.