MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIGRIP DENTURE ADHESIVE FORMULATION UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Death [unknown cause of death].Case description: this case was reported by a consumer and described the occurrence of death nos in a female patient who received gsk denture adhesive (formulation unknown) (poligrip denture adhesive formulation unknown) unknown for product used for unknown indication.On an unknown date, the patient started poligrip denture adhesive formulation unknown.On an unknown date, an unknown time after starting poligrip denture adhesive formulation unknown, 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 poligrip denture adhesive formulation unknown.Additional details: the patient was a poligrip user.This case was linked with gb2019eme195253 by same reporter, different patient.

Manufacturer Narrative

Argus case (b)(4).

Event Description

Case description: this case was reported by a consumer and described the occurrence of death nos in a female patient who received gsk denture adhesive (formulation unknown) (poligrip denture adhesive formulation unknown) unknown for product used for unknown indication.On an unknown date, the patient started poligrip denture adhesive formulation unknown.On an unknown date, an unknown time after starting poligrip denture adhesive formulation unknown, 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 poligrip denture adhesive formulation unknown.Additional details: the patient was a poligrip user.This case was linked with (b)(4) by same reporter, different patient.Follow up was received on (b)(6) 2020: the case was identified as non-valid because the patient experienced an incidental event, the case did not meet the criteria for valid entry.

• Brand Name: POLIGRIP DENTURE ADHESIVE FORMULATION UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford, ; EI
• MDR Report Key: 9580318
• MDR Text Key: 174667667
• Report Number: 3003721894-2019-00383
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other