MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA DENTURE CLEANSING TABLETS; 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 id: (b)(4).

Event Description

Her mother has accidentally taken a corega prosthesis cleansing tablet [accidental device ingestion].Case description: this case was reported by a other health professional 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 (batch number unk, expiry date unknown) 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).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/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from other health professional via call center representative (phone) on 17oct2022 and reported that "i am calling from a pharmacy because a customer has told me that her mother has accidentally taken a corega prosthesis cleansing tablet and we wanted to ask what to do, is it dangerous".Spanish narrative :llamo de una farmacia porque una clienta me ha dicho que su madre se ha tomado una pastilla de corega para limpiar la protesis sin querer y queriamos preguntar que tiene que hacer, es peligroso.

• Brand Name: COREGA DENTURE CLEANSING TABLETS
• 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 ; 8888255249
• MDR Report Key: 15734224
• MDR Text Key: 303069838
• Report Number: 1020379-2022-00030
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/04/2022
• 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
• Patient Sex: Female