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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROCTER & GAMBLE MANUFACTURING CO.FIXODENT DENTURE ADHESIVE, CONTROL FOOD SEAL PLUS SCOPE FLAVOR (CALCIUM ZINC GAN

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PROCTER & GAMBLE MANUFACTURING CO. FIXODENT DENTURE ADHESIVE, CONTROL FOOD SEAL PLUS SCOPE FLAVOR (CALCIUM ZINC GAN   Back to Search Results
Lot Number 11633
Event Type  Injury   Patient Outcome  Hospitalization,Other
Event Description

Everytime eats or drinks throws up [vomiting]. Nausea, upset stomach, sick to stomach [nausea]. Diarrhea [diarrhoea]. Dry mouth [dry mouth]. Device difficult to remove (cannot get the fixodent off the roof of mouth). [device difficult to use]. Case description: a consumer reported that they, an adult male age unspecified, used fixodent denture adhesive, control food seal puls scope flavor cream as advised by his dentist, unspecified total daily use for almost 2 weeks, last known use on (b)(6) 2011, and had to be hospitalized for 2 days after experiencing the following: every time he ate or drank anything he threw up, had nausea, upset stomach, was sick to stomach, had diarrhea, dry mouth / mouth did not have moisture, device difficult to remove (could not get the fixodent off the roof of his mouth). He consulted his dentist who said he had to get used to it. The consumer stated that he had to be taken to the hospital by ambulance. Treatment: omeprazole 20 mg capsules twice daily to keep the nausea down. The consumer discontinued use of fixodent and has had no problems with polygrip. The case outcome was recovered. Past medical history included: allergy - seasonal and (unspecified) food, medical history - has had denstures for 3 1/2 weeks. Concomitant medications included: percocet, valium, ambien, prozac, morphine, prilosec, albuterol, and adderall. No further info was provided.

 
Manufacturer Narrative

A lot check and batch retains were requested.

 
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Brand NameFIXODENT DENTURE ADHESIVE, CONTROL FOOD SEAL PLUS SCOPE FLAVOR (CALCIUM ZINC GAN
Type of DeviceDENTURE ADHESIVE
Manufacturer (Section F)
PROCTER & GAMBLE MANUFACTURING CO.
brown summit NC
Manufacturer (Section D)
PROCTER & GAMBLE MANUFACTURING CO.
brown summit NC
Manufacturer (Section G)
PROCTER & GAMBLE MANUFACTURING CO.
6200 bryan park road
brown summit NC 27214
Manufacturer Contact
8700 mason-montgomery rd
mason business center
mason , OH 45040-
Device Event Key2286444
MDR Report Key2265358
Event Key2162254
Report Number1530449-2011-00160
Device Sequence Number1
Product CodeKOO
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 08/26/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device LOT Number11633
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/26/2011
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 09/22/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
PERCOCET: (OXYCODONE HYDROCHLORIDE, OXYCODONE
TEREPHTHALATE, PARACETAMOL)
VALIUM (DIAZEPAM)
AMBIEN (ZOLPIDEM TARTRATE)
PROZAC (FLUOXETINE)
PRILOSEC (OMEPRAZOLE MAGNESIUM)
ALBUTEROL (SALBUTAMOL)
ADDERALL (AMFETAMINE ASPARTATE, AMFETAMINE SULFATE
DEXAMFETAMINE SACCHARATE, DESAMFETAMINE SULFATE)
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