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POLIDENT OVERNIGHT DENTURE CLEANSER

Received May 20, 2005 · Event occurred Apr 12, 2005

Report 1020379-2005-00005 · MDR key 606199

Device

Generic name

Denture Cleanser

Manufacturer

Glaxosmithkline

Model number

*

Catalog number

*

Lot number

MK304

Product problems

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

Patient

89 YR

  • Fever
  • Pneumonia
  • Vomiting
  • Regurgitation
  • Blood pressure, high
  • Treatment with medication(s)
  • Hospitalization required

Narrative

Description of Event or Problem

FOLLOW UP INFORMATION WAS RECEIVED IN 2005 IN THE FORM MEDICAL RECORDS. THE PATIENT UNDERWENT ESOPHAGOGASTRODUODENOSCOPY IN 2005, DUE TO COMPLAINTS OF DYSPHAGIA. THE PATIENT WAS DIAGNOSED WITH GASTRIC POLYPOP AND UNDERWENT A POLYPECTOMY AND SEVERELY ULCERETED MUCOSA UNDER THE EPIGLOTIS WAS NOTED. A MODERATE SIZE HISTAL HERNIA WAS NOTEDE AND NO HELICOBACTER PYLORI WAS NOTED. THE PATIENT WAS TREATED WITH PROTINIX. THE PATIENT WAS ALSO DIAGNOSED WITH SEVERE INFLAMMATION OF THE POSTERIOR PHARYNX AND VOCAL CHORDS AND WAS REFERRED TO SEE AN ENT SPECIALIST.

Description of Event or Problem

FOLLOW-UP INFO WAD RECEIVED IN 2005 IN THE FORM OF MED RECORDS. THE PT INDERWENT AN ESOPHAGOGASTRODUODENOSCOPY IN 2005 DUE TO COMPLAINTS OF DYSPHAGIA. PT WAS DIAGNOSED WITH A GASTRIC POLYP AND UNDERWENT A POLYPECTOMY AND SEVERELY ULCERATED MUCOSA UNDER THE EPIGLOTTIS WAS NOTED. A MODERATE SIZE HIATAL HERMIA WAS NOTED AND NO HELICOBACTER PYLORI WAS NOTED. THE PT WAS TREATED WITH PROTONIX. HE WAS ALSO DIAGNOSED WITH SEVERE INFLAMMATION OF THE POSTERIOR PHARYNX ND VOCAL CORDS AND WAS REFERRED TO SEE AN ENT SPECIALIST. ACCIDENTAL EXPOSURE, DRUG ADMINISTRATION ERROR, PHEUMONIA, VOMITING, THROAT IRRITATION, REGURGITATION OF FOOD, SPEECH DISORDER, MALAISE, BLOOD PRESSURE INCREASED, BODY TEMPERTURE INCREASED, PHARYNGOLARYNGEAL PAIN, DYSPHONIA, EATING DISORDER, HIATUS HERNIA, DYSPHAGIA, GASTRIC POLYPS, PHARYNGITIS, VOCAL CORD INFLAMMATION, ULCERATIVE LESION.

Description of Event or Problem

PT REPORTED THAT PT IS "SWEATING IT OUT" BECAUSE THEIR DOCTORS INFORMED THEM THAT IT WOULD BE ANOTHER MONTH BEFORE PT GETS THEIR VOICE BACK, ALTHOUGH THE CONSUMER WAS ABLE TO SPEAK. ALTHOUGH THE CONSUMER CONSENTED TO PROVIDE MEDICAL RECORDS, NONE HAVE BEEN RECEIVED.

Description of Event or Problem

IN 2005 THE PT ACCIDENTALLY INGESTED PART OF A POLIDENT (DENTAL) TABLET AFTER MISTAKING IT FOR A PIECE OF HARD TACK CANDY AND THE PT EXPERIENCED FEELING UNWELL, VOMITING FOR 30 MINUTES, THROAT BURNING, REGURGITATION AFTER DRINKING WATER, AND DIFFICULTY TALKING FOR LONG PERIODS DUE TO THE THROAT BURNING. THE PT WAS ADMITTED TO THE HOSP THE NEXT DAY AND EXPERIENCED AN ELEVATED BLOOD PRESSURE, A RISE IN TEMPERATURE, THEIR THROAT WAS RAW, THEIR VOICE RASPY AND PT HAD DIFFICULTY EATING. THE PT WAS DIAGNOSED WITH AN UNSPECIFIED PNEUMONIA AND TREATED WITH INTRAVENOUS ANTIBIOTICS, POTASSIUM SALT (POTASSIUM) AND A LIQUID DIET. THE PT WAS DISCHARGED ON 22 APRIL 2005 AND WAS GIVEN NO DISCHARGE MEDICATIONS OR INSTRUCTION. THE PT'S ELEVATION IN BLOOD PRESSURE AND TEMPERATURE, THROAT BURNING FEELING, THROAT RAWNESS, REGURGITATION AND DIFFICULTY EATING HAVE RESOLVED. THE PT VOICE REMAINS RASPY AND THE PT REPORTED THAT THE PHYSICIAN STATED HIS VOICE COULD REMAIN RASPY FOR MONTHS.