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

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus (b)(4), corega tabs bio formula.Corega tabs bio formula is marketed as polident in the us.

Event Description

Accidentally drunken corega tabs bio formula [accidental device ingestion].This case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a patient who received double salt denture cleanser 10791-02-001 (corega tabs bio formula) tablet for product used for unknown indication.On an unknown date, the patient started corega tabs bio formula.On an unknown date, an unknown time after starting corega tabs bio formula, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and wrong drug administered.On an unknown date, the outcome of the accidental device ingestion and wrong drug administered were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega tabs bio formula.Additional details: the consumer reported to have accidentally drunken corega tabs bio formula instead of magnesium.

• Brand Name: COREGA TABS BIO FORMULA
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6757564
• MDR Text Key: 81514492
• Report Number: 1020379-2017-00057
• 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: 07/23/2017

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
• Initial Date Manufacturer Received: 07/23/2017
• Initial Date FDA Received: 08/01/2017
• 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