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

I hadn't thrown out the water and by mistake i drank some water [accidental device ingestion].Prosthesis stayed in corega solution for a long time [wrong technique in device usage process].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 wrong technique in device usage process.The action taken with corega tabs was unknown.On an unknown date, the outcome of the accidental device ingestion and wrong technique in device usage process were unknown.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process 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 details: consumer had put the 'rote' (referring to roth a brand of dental prosthesis] inside the effervescent corega and stayed there for a long time and then she took that off, but she had not thrown out the water and by mistake she drank some water and she was scared.After she realized that, she drank a lot of water and ate a snack so that would not had an empty stomach.

• 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: 10569932
• MDR Text Key: 208153027
• Report Number: 1020379-2020-00045
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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: 08/27/2020
• 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