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

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 argus (b)(4), polident denture cleanser tablets.

Event Description

He passed away [unknown cause of death].Case description: this case was reported by a consumer and described the occurrence of unknown cause of death in a male patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date 2014) for product used for unknown indication.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 unknown cause of death (serious criteria death and gsk medically significant).On an unknown date, the outcome of the unknown cause of death was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the unknown cause of death to be related to polident denture cleanser tablets.Additional details, adverse event information was received on 11 may 2017.Consumer's wife reported she had a box that expired in 2014, her husband used it before expiration but he passed away on unknown date.

Manufacturer Narrative

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

Event Description

Case description: this case was reported by a consumer and described the occurrence of unknown cause of death in a male patient who received double salt denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date 2014) for product used for unknown indication.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 unknown cause of death (serious criteria death and gsk medically significant).On an unknown date, the outcome of the unknown cause of death was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the unknown cause of death to be related to polident denture cleanser tablets.Additional details, adverse event information was received on 11 may 2017.Consumer's wife reported she had a box that expired in 2014, her husband used it before expiration but he passed away on unknown date.Follow up information was received on 10 june 2017.The consumer reported that they disposed the product on unspecified date.Her husband died approximately 4 years ago.Patient died because of natural causes.The reporter considered the unknown cause of death to be unrelated to polident denture cleanser tablets.This case will be deleted from the database as there was no adverse event associated with the case.Comment: *downgrade report*.

• 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: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6572852
• MDR Text Key: 75367992
• Report Number: 1020379-2017-00039
• 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,Followup
• Report Date: 05/11/2017

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
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: 07/10/2017
• Supplement Dates FDA Received: 07/17/2017
• 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