SHOPPERS DRUG 2.4OZ DENTURE ADHESIVE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-01 for SHOPPERS DRUG 2.4OZ DENTURE ADHESIVE manufactured by Sheffield Pharmaceuticals.

Event Text Entries

[6021569] Patient stated that she used the denture adhesive and had allergic reaction and much of her face swelled. She seek medical attention.
Patient Sequence No: 1, Text Type: D, B5


[14149145] Complaint investigation still in progress. Suspect sample has not yet been returned to sheffield pharmaceuticals.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1210513-2015-00145
MDR Report Key4899071
Report Source07
Date Received2015-07-01
Date of Report2015-07-01
Date of Event2015-05-01
Date Mfgr Received2015-06-23
Date Added to Maude2015-07-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street170 BROAD ST.
Manufacturer CityNEW LONDON CT 06320
Manufacturer CountryUS
Manufacturer Postal06320
Manufacturer Phone8604424451
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHOPPERS DRUG 2.4OZ DENTURE ADHESIVE
Generic NameDENTURE ADHESIVE
Product CodeKOO
Date Received2015-07-01
Lot NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSHEFFIELD PHARMACEUTICALS
Manufacturer AddressNEW LONDON CT 06320 US 06320


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-01

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