SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2000-07-31 for SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM * manufactured by Block Drug Company, Inc..

Event Text Entries

[19173402] A consumer with no prior medical history used super poli-grip free denture adhesive cream twice daily on maxillary and mandibular dentures for 1 week and experienced abdominal cramps, abdominal pain, bloating and diarrhea. The consumer experienced "periodic" episodes of symptomatology after using the product for 1 week and each episode lasted several hours each time and recurred several times daily. The consumer noticed that these episodes seemed to occur after eating. The consumer reported that with ongoing symptomatology of 3 days duration and while continuing product use, visited an emergency room for treatment daily for 3 days during the second week of product use. X-rays of consumer's "stomach and intestine" were taken at the emergency room and the results were normal. The consumer reported that a c. A. T. Scan of consumer's stomach and lower intestine was normal. The consumer reported that the treating physician believed that the consumer was experiencing an abdominal infection and prescribed oral cipro and flagyl. The consumer was also prescribed chlordiazepoxide and endocet (oxycodone and acetaminophen). The consumer continued using super poli-grip free during this time period and continued to experience symptomatology. Despite of ongoing symptomatology, the consumer continued using the product and several days after last emergency room visit, the consumer returned to the hosp and was admitted; antibiotics did not seem to alleviate symptoms. While in the hosp the consumer underwent a colonoscopy and endoscopy and was informed by physician that results of the tests indicated an "allergic reaction," in stomach and intestine. Consumer was also informed by physician that colon and stomach were inflamed. Consumer was told by physician that diagnosis is an "allergic reaction," and dr did not know what the allergic reaction was to. The consumer did not report if the consumer was placed on a special diet or being treated by an allergist. The consumer was given prednisone and lomotil in the hosp and started "feeling better. " the consumer's symptoms of abdominal pain and bloating resolved approximately 2 and 1/2 weeks after onset. The consumer was discharged from the hospital 6 days after admission and sent home on prednisone and lomotil as needed, therapy. The consumer continues to experience periodic episodes of cramps and diarrhea, and symptoms have decreased in intensity and frequency; there was no longer any temporal relationship between these symptoms and eating meals or product use. Consumer used the same tube of super poli-grip free up to and including hospital stay and did not notice any oral symptomatology at any time. When consumer arrived home after being discharged from the hospital, the consumer noticed when the consumer went to use super poli-grip free that consumer's oral mucosa was red and inflamed. The consumer had a similar reaction to fixodent several years earlier. The consumer applied the super poli-grip free that the consumer had been using all along and immediately experienced burning and lost the consumer's sense of taste because taste buds felt numb. The consumer removed the product and all oral symptomatology resolved 1 day later. The consumer believed that the consumer was allergic to super poli-grip free. The consumer believed that experienced oral inflammation and erythema for approximately 3 weeks but did not notice this until after coming home from the hospital. The consumer informed physician of this experience with super poli-grip free and was told by physician that physician does not believe that systemic symptoms were caused by the use of super poli-grip free. Prior to using super poli-grip free, the consumer used poli-grip free (which is the same formula) for several years without incident and has since found a tube of poli-grip free and has been using it uneventfully. Additional follow-up planned with physician, however, at the time of this report, no additional info was available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2650037-2000-00001
MDR Report Key289004
Report Source04,05
Date Received2000-07-31
Date of Report2000-07-10
Date of Event2000-06-01
Date Mfgr Received2000-06-12
Device Manufacturer Date1999-11-01
Date Added to Maude2000-08-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street257 CORNELISON AVENUE
Manufacturer CityJERSEY CITY NJ 073023198
Manufacturer CountryUS
Manufacturer Postal073023198
Manufacturer Phone2014343000
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPER POLIGRIP FREE DENTURE ADHESIVE CREAM
Generic NameDENTURE ADHESIVE
Product CodeKOP
Date Received2000-07-31
Model Number*
Catalog Number*
Lot NumberHK099
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key279678
ManufacturerBLOCK DRUG COMPANY, INC.
Manufacturer Address257 CORNELISON AVENUE JERSEY CITY NJ 073023198 US


Patients

Patient NumberTreatmentOutcomeDate
111. Hospitalization 2000-07-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.