WALMART EQUATE 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 WALMART EQUATE DENTURE ADHESIVE manufactured by Sheffield Industries, Div. Of Faria Ltd..

Event Text Entries

[6021053] Patient states that the product caused her to get blisters inside her mouth. She also states that this has never happened to her before.
Patient Sequence No: 1, Text Type: D, B5


[14251276] 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 Number1210513-2015-00144
MDR Report Key4899089
Report Source07
Date Received2015-07-01
Date of Report2015-07-01
Date of Event2015-06-12
Date Mfgr Received2015-06-17
Device Manufacturer Date2015-02-01
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 Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALMART EQUATE DENTURE ADHESIVE
Generic NameDENTURE ADHESIVE
Product CodeKOO
Date Received2015-07-01
Lot Number50161
OperatorLAY USER/PATIENT
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSHEFFIELD INDUSTRIES, DIV. OF FARIA LTD.
Manufacturer AddressNEW LONDON CT 06320 US 06320


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-01

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