MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA TABS; 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  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Corega tabs was accidentally ingested [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 patient who received denture cleanser (corega tabs) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started corega tabs.On an unknown date, an unknown time after starting corega tabs, the patient experienced accidental device ingestion (serious criteria haleon medically significant).The action taken with corega tabs 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 tabs.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information received from a consumer via call center representative (email) on 07jan2024.The consumer reported that, "corega tabs was accidentally ingested.What effects could there be? and is there anything that can be taken?".The suspect product was reported as corega tabs generic.

• Brand Name: COREGA TABS
• 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
• MDR Report Key: 18550534
• MDR Text Key: 333314672
• Report Number: 1020379-2024-00002
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 01/07/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2024
• Initial Date FDA Received: 01/22/2024
• 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