MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER TABLETS

Lot Number K161413A

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

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

This report is associated with (b)(4), polident denture cleanser tablets.

Event Description

Death nos [unknown cause of death].Case description: this case was reported by a consumer and described the occurrence of death nos in a (b)(6) female patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number k161413a, expiry date unknown) for dental cleaning.The patient's past medical history included cancer.On an unknown date, the patient started polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture cleanser tablets, the patient experienced death nos (serious criteria death and gsk medically significant).On (b)(6) 2017, the outcome of the death nos was fatal.The patient died on (b)(6) 2017.The reported cause of death was unknown cause of death.An autopsy was performed.It was unknown if the reporter considered the death nos to be related to polident denture cleanser tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, adverse event information was received on 27 june 2017.The consumer stated his wife passed away after using the polident.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: withheld ; po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6682586
• MDR Text Key: 78895060
• Report Number: 1020379-2017-00051
• Device Sequence Number: 1
• Product Code: EFT
• 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
• Type of Report: Initial
• Report Date: 06/27/2017

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
• Device Lot Number: K161413A
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 78 YR