SUPER COREGA POWDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-18 for SUPER COREGA POWDER manufactured by Glaxosmithkline Dungarvan Ltd..

Event Text Entries

[25144337] Suspected poisoning; complications (ill-defined disorder). Case description: this case was reported by a consumer via call center presentative and described the occurrence of poisoning in a female patient who received denture adhesive power-cmc or double salt (super corega powder) oral powder for product used for unknown indication. On an unknown date, the patient started super corega powder. On an unknown date, an unknown time after starting super corega powder, the patient experienced poisoning (serious criteria gsk medically significant) and ill-defined disorder. On an unknown date, the outcome of the poisoning and ill-defined disorder were not reported. It was unknown if the reporter considered the poisoning and ill-defined disorder to be related to super corega powder. 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. This case was reported by a consumer via call center. On (b)(4) 2015 the consumer left a voice mail reporting that she used super corega powder and was presented some complications, she thought that could be a poisoning. Due to this, she decided to sent this voice mail, tried to clarify this issue. Action taken for device was unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003721894-2015-00004
MDR Report Key5025348
Date Received2015-08-18
Date of Report2015-08-11
Date Mfgr Received2015-08-11
Date Added to Maude2015-08-24
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 FDA3
Event Location3
Manufacturer StreetPO BOX 13398
Manufacturer CityRESEARCH TRIANGLE PARK NC 277090000
Manufacturer CountryUS
Manufacturer Postal277090000
Manufacturer Phone8888255249
Manufacturer G1GLAXOSMITHKLINE DUNGARVAN LTD.
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSUPER COREGA POWDER
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-08-18
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKLINE DUNGARVAN LTD.
Manufacturer AddressDUNGARVAN EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-08-18

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