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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Accidental drug intake [accidental device ingestion].Case description: this case was reported by a consumer via local affiliate and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (corega tabs) unknown for drug use for unknown indication.Concomitant products included levothyroxine sodium (puran t4 (levothyroxine sodium)).On an unknown date, the patient started corega tabs.On an unknown date, an unknown time after starting corega tabs, the patient experienced accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion to be related to corega tabs.Additional information: the action taken with corega tabs is unknown.Patient reported she accidentally ingested corega tabs together with puran t4 (levothyroxine sodium).Batch number was not provided.Age or age group were not provided.

• 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: 7181953
• MDR Text Key: 96971551
• Report Number: 1020379-2018-00003
• 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: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• 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
• Treatment: PURAN T4 (LEVOTHYROXINE SODIUM)
• Patient Outcome(s): Other