MAUDE Adverse Event Report: BLOCK DRUG CO., INC. COREGA TABS 3 MINUTEN; 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

Patient took half a tab 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 tabs 3 minuten) tablet for drug use for unknown indication.On an unknown date, the patient started corega tabs 3 minuten.On an unknown date, an unknown time after starting corega tabs 3 minuten, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with corega tabs 3 minuten 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 tabs 3 minuten.Additional details: the reporter's mother had by mistake, taken half a tab of corega 3 minutes cleanser.The reporter wanted to knew he/she had to do anything.What could happened.

• Brand Name: COREGA TABS 3 MINUTEN
• 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: 9482545
• MDR Text Key: 187954839
• Report Number: 1020379-2019-00057
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 11/21/2019
• 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