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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Report# 1020379-2019-00011 is associated with argus case (b)(4), corega tabs 3 minuten.Corega tabs 3 minuten is marketed as polident in the us.

Event Description

Accidental intake of product (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 (b)(6) year-old male patient who received denture cleanser (corega tabs 3 minuten) tablet for product used for unknown indication.Concurrent medical conditions included alzheimer's disease and renal failure.On an unknown date, the patient started corega tabs 3 minuten.On (b)(6) 2019, an unknown time after starting corega tabs 3 minuten, the patient experienced accidental device ingestion (serious criteria gsk medically significant).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 consumer, in took one tablet of corega tabs 3 minuten by error.The reporter was the consumer's daughter.As additional information, the consumer was under treatment with concomitant medications but the reporter could not specify the trade names.

• 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: 8350875
• MDR Text Key: 136520776
• Report Number: 1020379-2019-00011
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 02/11/2019
• 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
• Patient Age: 94 YR
• Patient Weight: 83