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 No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

She has been putting in her mouth she thinks its candy/ she was thinking it was mints [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included denture wearer and short-term memory loss.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 accidental device ingestion (serious criteria gsk medically significant) and intercepted product administration error.The action taken with polident denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion and intercepted product administration error were unknown.It was unknown if the reporter considered the accidental device ingestion 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 via call on 24 june 2020.Consumer called in about polident denture cleanser tablets and had a question to ask.The consumer's sister that was just put in a home last week she has denture, and her niece told that she had been putting in her mouth she thought it was candy, the consumer did not know if she should call poison control, they stopped her from taking it.The patient thought it was mints.The consumer reported that you would not be able to get any information out of her, she did not remember what she did yesterday.No further information was provided.

• Brand Name: POLIDENT 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; 8888255249
• MDR Report Key: 10313742
• MDR Text Key: 207332864
• Report Number: 1020379-2020-00034
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• 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): Other