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

Lot Number UNKNOWN

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Death nos [unknown cause of death].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental ingestion of product in a male patient who received denture cleanser (polident overnight denture cleanser tablets) tablet for denture wearer(as denture cleanser tablet for product used for unknown indication.On an unknown date, the patient started polident overnight denture cleanser tablets at an unknown dose and frequency.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced accidental ingestion of product.The action taken with polident overnight denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental ingestion of product was unknown.Additional details: the consumer swallowed polident before bedtime cleanser product mistakenly.Follow up information received from the consumer on 10 nov 2020: on an unknown date, an unknown time after starting polident overnight denture cleanser tablets, 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 polident overnight denture cleanser tablets.The patient was a elderly male.The reporter mentioned that his father(consumer) passed away some time ago.His father was old anyway the reporter said.The reporter said gsk does not have to collect information because the product that the customer swallowed was not gsk's product.He thought it was gsk's product however later it was found to be other companies' product, therefore gsk does not seem to have any obligation to do anything, and he does not have to provide further information he said.Fu was closed.Upon internal review the case needs to be deleted due to no gsk suspect product and incidental death of patient.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 10905225
• MDR Text Key: 218489455
• Report Number: 1020379-2020-00060
• 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,foreign
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2020
• 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