ULTRA COREGA CREAM MINT FLAVOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-07 for ULTRA COREGA CREAM MINT FLAVOR manufactured by Gsk Dungarvan Stafford Miller.

Event Text Entries

[5606918] Hypertensive crisis (hypertensive crisis). Case description: this case was reported by a physician via call center representative and described the occurrence of hypertensive crisis in a (b)(6) male patient who received double salt dental adhesive cream (ultra corega cream min flavor) cream (batch number nt3v, expiry date unk) for product used for unknown indication. Concomitant products included enalapril and atenolol. On (b)(6) march 2015, the patient started ultra corega cream mint flavor. On an unknown date, an unknown time after starting ultra corega cream mint flavor, the patient experienced hypertensive crisis (serious criteria gsk medically significant). On an unknown date, the outcome of the hypertensive crisis was unknown. It was unknown if the reporter considered the hypertensive crisis to be related to corega cream mint flavor. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional information included, the consumer had started using the product on (b)(6) 2015 and on an unknown date patient presented with a hypertensive crisis. Reporter informed that consumer used the product according to product label. His physician had called to gsk since corega was the only thing that have changed in consumer habits and it contains salt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681138-2015-00014
MDR Report Key4667480
Report Source01,05
Date Received2015-04-07
Date of Report2015-03-17
Date Mfgr Received2015-03-17
Date Added to Maude2015-05-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer StreetP.O BOX 13398
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone8888255249
Manufacturer G1GSK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRA COREGA CREAM MINT FLAVOR
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-04-07
Lot NumberNT3V
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGSK DUNGARVAN STAFFORD MILLER
Manufacturer AddressDUNGARVAN EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-04-07

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