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 Discomfort (2330)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Argus case id (b)(4).

Event Description

He was supposed to put the tablet in a cup to clean his teeth and he chewed it.He said his stomach is starting to feel funny.[accidental device ingestion].He said his stomach is starting to feel funny [stomach discomfort].He was supposed to put the tablet in a cup to clean his teeth and he chewed it [wrong technique in device usage process].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) male patient who received denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for dental cleaning.On (b)(6) 2020, the patient started polident denture cleanser tablets.On (b)(6) 2020, less than a day after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant), stomach discomfort and wrong technique in device usage process.Polident denture cleanser tablets was discontinued on (b)(6) 2020 (dechallenge was unknown).On an unknown date, the outcome of the accidental device ingestion, stomach discomfort and wrong technique in device usage process were unknown.It was unknown if the reporter considered the accidental device ingestion, stomach discomfort and wrong technique in device usage process 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 information, adverse event information received via call center representative on (b)(6) 2020.Reporter stated that "i made a mistake and they gave a product to use and i missed used it.It says daily cleaner polident cleaner.He took something.The dentist gave his something to clean his teeth.It was a tablet to clean his teeth.He was supposed to put the tablet in a cup to clean his teeth and he chewed it.He doesn't have the box so i don't know which one it is.On the back of the package it says do not place in your mouth and keep out of reach of children.Is it poison or will it give him diarrhea.He said his stomach is starting to feel funny.I tried calling my doctor but they are closed its friday".

• 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, NC 27709 ; 8888255249
• MDR Report Key: 9799377
• MDR Text Key: 193324705
• Report Number: 1020379-2020-00007
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• 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: 02/07/2020
• 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
• Patient Age: 56 YR