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

Lot Number 6F3G

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Drank all the corega 3min solution that was in his glass [accidental device ingestion].Case description: this case was reported by a pharmacist via call center representative and described the occurrence of accidental device ingestion in a elderly male patient who received denture cleanser (corega denture cleansing tablets) tablet (batch number 6f3g, expiry date 31st january 2022) for drug use for unknown indication.On (b)(6) 2020, the patient started corega denture cleansing tablets.On an unknown date, an unknown time after starting corega denture cleansing tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).(dechallenge 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 without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the patient drank all the corega three minute solution that was in his glass.The patient called the doctor, who told him that he should not have drunk it and did not give him any other advice.The patient drank a lot of water and urinated three times and has not felt any discomfort or other adverse event and went to the pharmacy alone.As the customer was old, the pharmacist did not try to explain the process to him.The pharmacist would also call the poison center.The patient does not experience any reaction.Consumer treated by an health care professional.

• Brand Name: COREGA DENTURE CLEANSING 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: 10301392
• MDR Text Key: 207333323
• Report Number: 1020379-2020-00035
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Lot Number: 6F3G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• 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