MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA TOTAL ACTION; DENTURE CLEANSER

Lot Number TE9M

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Has taken by mistake [accidental device ingestion], vomiting [vomiting].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a (b)(6) male patient who received denture cleanser (corega total action) tablet (batch number te9m, expiry date 28th february 2023) for denture wearer.On an unknown date, the patient started corega total action at an unknown dose and frequency.On (b)(6) 2020, an unknown time after starting corega total action, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the patient experienced vomiting.The action taken with corega total action was unknown.On an unknown date, the outcome of the accidental device ingestion and vomiting were unknown.It was unknown if the reporter considered the accidental device ingestion and vomiting to be related to corega total action.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 had taken corega action total tablet (pastilla limpiadora corega acción total) by mistake and, since last night was vomiting continuously.Spanish text: ha tomado por error la pastilla limpiadora corega acción total y desde anoche está vomitando continuamente.

• Brand Name: COREGA TOTAL ACTION
• 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: 10894950
• MDR Text Key: 217992586
• Report Number: 1020379-2020-00058
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2020

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
• Device Expiration Date: 02/28/2023
• Device Lot Number: TE9M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/24/2020
• 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
• Patient Age: 88 YR