MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE DENTURE CLEANSER TABLETS

Lot Number 839F

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

Patient Problem Abdominal Pain (1685)

Event Date 02/26/2023

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I accidentally drank your polident last night.[accidental device ingestion] stomach so that hurts [stomach pain].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a 78-year-old female patient who received denture cleanser (polident 3 minute denture cleanser tablets) tablet (batch number 839f, expiry date 31st october 2024) for drug use for unknown indication.On (b)(6) 2023, the patient started polident 3 minute denture cleanser tablets.In (b)(6) 2023, an unknown time after starting polident 3 minute denture cleanser tablets, the patient experienced stomach pain.On (b)(6) 2023, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Polident 3 minute denture cleanser tablets was discontinued on (b)(6) 2023 (dechallenge was positive).On an unknown date, the outcome of the accidental device ingestion and stomach pain were recovering/resolving.It was unknown if the reporter considered the accidental device ingestion and stomach pain to be related to polident 3 minute denture cleanser tablets.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer on 27feb2023 via call center representative (phone).The consumer reported that "i accidentally drank your polident last night.I called poision control and an ambulance came to.I have problems with my stomach so that hurts.But i am felling better now.I was wondering if i will feel better".

• Brand Name: POLIDENT 3 MINUTE DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 16564007
• MDR Text Key: 311479593
• Report Number: 1020379-2023-00011
• 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: 02/27/2023

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: 839F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/17/2023
• 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: 78 YR
• Patient Sex: Female