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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Complaint, Ill-Defined (2331); Malaise (2359)

Event Type  Injury  

Manufacturer Narrative

The report # 1020379-2018-00001 is associated with (b)(4), corega tabs.Corega tabs is marketed as polident tablets in the u.S.

Event Description

Accidental ingestion [accidental device ingestion].Malaise [malaise].Case description: this case was reported by a pharmacist via call center representative and described the occurrence of accidental device ingestion in a patient who received denture cleanser (corega tabs) tablet for product used for unknown indication.On an unknown date, the patient started corega tabs at an unknown dose and frequency.On an unknown date, an unknown time after starting corega tabs, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and malaise.The action taken with corega tabs was unknown.On an unknown date, the outcome of the accidental device ingestion and malaise were not reported.It was unknown if the reporter considered the accidental device ingestion and malaise to be related to corega tabs.Additional information: consumer reported to pharmacist, who called to call center and informed that consumer ingested corega tabs accidentally and experienced malaise.

• Brand Name: COREGA TABS
• 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: 7185319
• MDR Text Key: 97059510
• Report Number: 1020379-2018-00001
• 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: foreign,health professional
• Type of Report: Initial
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 01/04/2018
• 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