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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); UNKNOWN
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GLAXOSMITHKLINE DUNGARVAN LTD COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); UNKNOWN Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
Argus case id (b)(4).
 
Event Description
Death [unknown cause of death].Case description: this case was reported by a consumer via call center representative and described the occurrence of death nos in a female patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for product used for unknown indication.On an unknown date, the patient started corega (unspecified denture adhesive or denture cleanser).On an unknown date, an unknown time after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced death nos (serious criteria death and gsk medically significant).On an unknown date, the outcome of the death nos was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the death nos to be related to corega (unspecified denture adhesive or denture cleanser).Additional details: the consumer mentioned that once he got free samples for his mother, who was already dead.
 
Manufacturer Narrative
Argus case (b)(4).
 
Event Description
Case description: this case was reported by a consumer via call center representative and described the occurrence of death nos in a female patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for product used for unknown indication.On an unknown date, the patient started corega (unspecified denture adhesive or denture cleanser).On an unknown date, an unknown time after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced death nos (serious criteria death and gsk medically significant).On an unknown date, the outcome of the death nos was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the death nos to be related to corega (unspecified denture adhesive or denture cleanser).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the consumer mentioned that once he got free samples for his mother, who was already dead.Follow up information received on 10 may 2019: the loc mentioned that they have received a cioms of this case which clearly states that the reporter's mother died after using product corega.However, when observed the original and source documents, it was not clear if the patient had actually used the product before the outcome was reported.The verbatim only stated that his mother had received free samples.Therefore, they were requested to send this note and inform that we do not have the information that the patient used the product before her death, however, a more conservative approach was adopted and loc reported the case to the competent authority.
 
Manufacturer Narrative
Argus case (b)(4).
 
Event Description
Case description: this case was reported by a consumer via call center representative and described the occurrence of death nos in a female patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for product used for unknown indication.On an unknown date, the patient started corega (unspecified denture adhesive or denture cleanser).On an unknown date, an unknown time after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced death nos (serious criteria death and gsk medically significant).On an unknown date, the outcome of the death nos was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the death nos to be related to corega (unspecified denture adhesive or denture cleanser).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the consumer mentioned that once he got free samples for his mother, who was already dead.Follow up information received on 10 may 2019: the loc mentioned that they have received a cioms of this case which clearly states that the reporter's mother died after using product corega.However, when observed the original and source documents, it was not clear if the patient had actually used the product before the outcome was reported.The verbatim only stated that his mother had received free samples.Therefore, they were requested to send this note and inform that we do not have the information that the patient used the product before her death, however, a more conservative approach was adopted and loc reported the case to the competent authority.Follow up information was received from quality assurance department on (b)(6) 2019.Qa analysis revealed the complaint to be unsubstantiated.The corega (corega (unspecified denture adhesive or denture cleanser)) unknown (batch number xp0012v, expiry date (b)(6) 2021) was updated.This case was associated with a product complaint.This report is being resubmitted to capture corrections.The information was received on (b)(6) 2019 as follows the suspect drug corega (corega (unspecified denture adhesive or denture cleanser)) unknown (batch number xp0012v, expiry date (b)(6) 2021) it was unknown if the reporter considered the unknown cause of death to be related to corega (unspecified denture adhesive or denture cleanser) was updated.This report is being resubmitted to capture corrections.The information was received on (b)(6) 2019 as follows the suspect product corega (unspecified denture adhesive or denture cleanser) recoded from corega ultra powder.The follow up information that was previously received from quality assurance department on (b)(6) 2019, was erroneously reported in case (b)(4) and belongs to case (b)(4); please see case (b)(4) for details.
 
Event Description
Case description: this case was reported by a consumer via call center representative and described the occurrence of death nos in a female patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for product used for unknown indication.On an unknown date, the patient started corega (unspecified denture adhesive or denture cleanser).On an unknown date, an unknown time after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced death nos (serious criteria death and gsk medically significant).On an unknown date, the outcome of the death nos was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the death nos to be related to corega (unspecified denture adhesive or denture cleanser).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the consumer mentioned that once he got free samples for his mother, who was already dead.Follow-up information received on 10 may 2019: the loc mentioned that they have received a cioms of this case which clearly states that the reporter's mother died after using product corega.However, when observed the original and source documents, it was not clear if the patient had actually used the product before the outcome was reported.The verbatim only stated that his mother had received free samples.Therefore, they were requested to send this note and inform that we do not have the information that the patient used the product before her death, however, a more conservative approach was adopted and loc reported the case to the competent authority.Follow-up information was received from quality assurance department on 23 jul 2019.Qa analysis revealed the complaint to be unsubstantiated.The corega (corega (unspecified denture adhesive or denture cleanser)) unknown (batch number xp0012v, expiry date 30th november 2021) was updated.This case was associated with a product complaint.This report is being resubmitted to capture corrections.The information was received on 30 apr 2019 as follows the suspect drug corega (corega (unspecified denture adhesive or denture cleanser)) unknown (batch number xp0012v, expiry date 30th november 2021) it was unknown if the reporter considered the unknown cause of death to be related to corega (unspecified denture adhesive or denture cleanser) was updated.This report is being resubmitted to capture corrections.The information was received on 23 jul 2019 as follows the suspect product corega (unspecified denture adhesive or denture cleanser) recoded from corega ultra powder.The follow up information that was previously received from quality assurance department on 23 july 2019, was erroneously reported in case (b)(4) and belongs to case (b)(4); please see case (b)(4) for details.Upon internal review, the case was identified as non valid because the patient experienced an incidental event, the case did not meet the criteria for valid entry.The case is deleted.
 
Manufacturer Narrative
Due to argus limitation, this fu2 report for 3003721894-2019-00123 was submitted via esg as a fu3.Mfr#: 3003721894-2019-00123 is associated with case (b)(4).
 
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Brand Name
COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
Type of Device
UNKNOWN
Manufacturer (Section D)
GLAXOSMITHKLINE DUNGARVAN LTD
dungarvan,
waterford,
EI 
MDR Report Key8607538
MDR Text Key144972819
Report Number3003721894-2019-00123
Device Sequence Number1
Product Code KOT
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup,Followup
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/30/2019
Initial Date FDA Received05/14/2019
Supplement Dates Manufacturer Received05/10/2019
07/23/2019
02/27/2020
Supplement Dates FDA Received05/20/2019
10/01/2019
03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Other;
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