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 No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Drunk the product by mistake [accidental device ingestion].She had a scratchy throat [throat irritation].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 (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 gsk medically significant) and throat irritation.On an unknown date, the outcome of the accidental device ingestion was unknown and the outcome of the throat irritation was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion and throat irritation to be related to corega tabs.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information, the case is received via email.Consumers wife drunk from his corega taps by mistake, reporter would like to know what he can do and if this would be dangerous.She had a scratchy throat, but after a few glasses of water, the scratchy feeling disappeared.

• Brand Name: COREGA TABS
• 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: 10527312
• MDR Text Key: 206790299
• Report Number: 1020379-2020-00040
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 08/16/2020

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: 08/16/2020
• Initial Date FDA Received: 09/14/2020
• 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): Death; Other