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

Lot Number UNKNOWN

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

Swallowed 10 ml of the solution, in which the corega 4 in 1 cleaning tablets were dissolved by mistake [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 female patient who received denture cleanser (corega denture cleansing tablets) tablet for product used for unknown indication.On an unknown date, 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 and other: gsk medically significant).The action taken with corega denture cleansing tablets 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: a female subject (age not provided) in the morning of (b)(6) 2020 swallowed 10 ml of the solution, in which the corega 4 in 1 cleaning tablets were dissolved by mistake.At the time of reporting, the subject did not have any symptoms of any aes (adverse event), but was very upset because of the toxicity explanations on the pack.

• 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; 8888255249
• MDR Report Key: 10465180
• MDR Text Key: 205006394
• Report Number: 1020379-2020-00039
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• 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