SUPER PILO-GRIP DENTURE ADHESIVE CREAM-ULTIMATE HOLD *

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 1996-12-20 for SUPER PILO-GRIP DENTURE ADHESIVE CREAM-ULTIMATE HOLD * manufactured by Block Drug Co., Inc..

Event Text Entries

[37184] 53 yr old male consumer experienced an immediate metallic taste following initial application of denture adhesive. Four hours later, he experienced swelling and a milky white coating of the tongue. His taste buds "stood up out of his tongue". In the evening the consumer removed the denture and adhesive. He awoke with symptoms continuing. Consumer presented to an emergency clinic physician who prescribed an unk "antibiotic". Symptoms resolved four days after discontinuing use of device. Consumer then used denture adhesive double salt formulation uneventfully for four months/ consumer then used one application of device from a second tube one evening. He awoke the next morning with metallic taste, tongue swelling and milky white coating on the tongue. His taste buds "stood up out of this tongue". While eating, the consumer experienced taste alteration, then experienced face and lip swelling. Consumer removed the denture, and in so doing, pulled and left hanging a piece of skin from the upper gums. The next day the consumer went to his physician who presribed augmentin 875 mg for a possible infection. With swelling abating, then increasing, consumer returned the next day to a physician. This physician recommended that the consumer present to the hosp er, as he believed that the consumer was experiencing a cavernous sinus infection. At the hosp er, ent specialist detained the consumer 23 hours in the short term observation unit. Preliminary diagnoses included angioedema, allergic reaction, or cellulitis. Consumer was administered oral antibiotics, benadryl and lortab, along with iv fluids. Consumer underwent blood work which indicated no elevation of the white blood cells nor eosinophilic cells. Additionally, a c1 esterase allergy test was performed, the results of which are unavailable. A scan indicated no sinus involvement. Face swelling resolved two days after discontinuing use of ispg; lip and tongue swelling along with the milky white coating four days after discontinuing use of device; metallic taste and taste alteration four days after discontinuing use of device. Two days after release from the short term observation unit, the consumer was re-evaluated by the ent specialist who noticed marked improvement. Ten days after use of device was discontinued the residual pain resloved, although the piece of skin remains hanging from the top gums. Further follow-up is needed with the consumer and ent specialist following receipt of the ingredients by the ent. Unused product is unavailiable, however, consumer was able to provide the lot number from the box of the second tube.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2650037-1996-00001
MDR Report Key58339
Report Source04,05
Date Received1996-12-20
Date of Report1996-12-18
Date of Event1996-11-29
Date Mfgr Received1996-12-02
Device Manufacturer Date1996-06-01
Date Added to Maude1996-12-30
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 Location3
Manufacturer Street257 CORNELISON AVE
Manufacturer CityJERSEY CITY NJ 073023198
Manufacturer CountryUS
Manufacturer Postal073023198
Manufacturer Phone2014343000
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPER PILO-GRIP DENTURE ADHESIVE CREAM-ULTIMATE HOLD
Generic NameDENTURE ADHESIVE
Product CodeKOP
Date Received1996-12-20
Model Number*
Catalog Number*
Lot NumberHF056
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age*
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key58797
ManufacturerBLOCK DRUG CO., INC.
Manufacturer Address257 CORNELISON AVE JERSEY CITY NJ 073023198 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 1996-12-20

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