COREGA ULTRA CREAM WITHOUT FLAVOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,04 report with the FDA on 2015-06-29 for COREGA ULTRA CREAM WITHOUT FLAVOR manufactured by Glaxosmithkline Dungarvan Ltd..

Event Text Entries

[6057222] Death (unknown cause) [unknown cause of death]. Case description: this case was reported by a consumer via call center representative and described the occurrence of death (unknown cause) in a (b)(6) male patient who received triple sale dental adhesive cream (corega ultra cream without flavor) cream for oral prothesis fixation. On an unknown date, the patient started corega ultra cream without flavor. The patient experienced death (unknown cause) (serious criteria death, gsk medically significant and other: gsk medically significant). On an unknown date, the outcome of the death (unknown cause) was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death (unknown cause) to be related to corega ultra cream without flavor. Case reported by distributor (initially on (b)(6) 2014). Patient used corega adhesive cream due to prothesis fixation. Relative reported that patient died due to (unknown cause). She does not give more information and there's no authorization to contact physician. Case was considered closed. Case originally reported as a post-marketing surveillance case. Follow up information was received on 10/13/2014. This case is a spontaneous case reported through a distributor who has also a call center.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681138-2015-00033
MDR Report Key4877676
Report Source00,01,04
Date Received2015-06-29
Date of Report2014-09-30
Date Mfgr Received2014-09-30
Date Added to Maude2015-06-30
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 NameCOREGA ULTRA CREAM WITHOUT FLAVOR
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-06-29
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKLINE DUNGARVAN LTD.
Manufacturer AddressDUNGARVAN EI


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Other 2015-06-29

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