MAUDE Adverse Event Report: BLOCK DRUG CO., INC COREGA DENTURE CLEANSING TABLETS; DENTURE CLEANSER

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  Injury  

Event Description

Accidentally swallowed the water where a corega tablet was [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 male patient who received denture cleanser (corega denture cleansing tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started corega denture cleansing tablets.In (b)(6) 2023, an unknown time after starting corega denture cleansing tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with corega denture cleansing tablets was unknown.On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega denture cleansing 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 a consumer via call center representative (phone) on (b)(6) 2023.It was reported that "i'm calling to say that i accidentally swallowed the water where a corega tablet was last night.I hadn't realized it.Something happens, is it dangerous".

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: COREGA DENTURE CLEANSING 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: 16712502
• MDR Text Key: 313015542
• Report Number: 1020379-2023-00013
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2023
• 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 Sex: Male