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

I'm calling because my mother accidentally swallowed one of the corega pills [accidental device ingestion].Stomach discomfort [stomach discomfort].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 (corega tabs) tablet for dental cleaning.On an unknown date, the patient started corega tabs at an unknown dose and frequency.On an unknown date, an unknown time after starting corega tabs, the patient experienced accidental device ingestion (serious criteria haleon medically significant) and stomach discomfort.The action taken with corega tabs was unknown.On an unknown date, the outcome of the accidental device ingestion and stomach discomfort were unknown.It was unknown if the reporter considered the accidental device ingestion and stomach discomfort to be related to corega tabs.Additional details: adverse event information was received by consumer via call center representative (phone) on 05feb2024.The consumer reported,i'm calling because my mother accidentally swallowed one of the corega pills used to clean her teeth and is here with stomach discomfort".Suspect drug: corega cleanser tablet - unknown variant and size.

• 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: 18718808
• MDR Text Key: 335527899
• Report Number: 1020379-2024-00004
• 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: 02/05/2024

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: 02/05/2024
• Initial Date FDA Received: 02/16/2024
• 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: Female