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

Lot Number 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

Passed away [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 male patient who received denture cleanser (polident whitening tablets) tablet for dental care and oral hygiene.On an unknown date, the patient started polident whitening tablets at an unknown dose and frequency.On an unknown date, an unknown time after starting polident whitening 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 whitening tablets.Additional details: the reporter stated about the polident she had, which expired in 2016 and asked if it was yet good.The reporter had it from her husband who passed away.This case was linked with (b)(4) (same reporter).Clarification received on 09 sep 2020: upon internal review the case is now invalid because the patient experienced an incidental event, the case did not meet the criteria for valid entry.There was no suggestion from the reporter that the death (nos) was related to product use, and the case was linked to an enquiry about using expired product from the reporter's husband who'd passed away (similarly no reported relation to product use).

• Brand Name: POLIDENT WHITENING 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: 10559632
• MDR Text Key: 207721726
• Report Number: 1020379-2020-00042
• 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: 08/24/2020

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/21/2020
• 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