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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Reaction (2414)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Accidental ingestion [accidental device ingestion by a child].Facial redness [red face].Case description: this case was reported by a physician via out of hour services and described the occurrence of accidental device ingestion by a child in a (b)(6) female patient who received denture cleanser (corega tabs) unknown for drug use for unknown indication.Concurrent medical conditions included allergy (many kind of allergies (not specified)).On (b)(6) 2016, the patient started corega tabs.On (b)(6) 2016, an unknown time after starting corega tabs, the patient experienced accidental device ingestion by a child (serious criteria gsk medically significant) and red face.On an unknown date, the outcome of the accidental device ingestion by a child was not reported and the outcome of the red face was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion by a child and red face to be related to corega tabs.Additional information: the hcp informed that the user of the product is the patient mother.The hcp also informed that the patient is on the emergency (not hospitalized) presenting facial redness, symptom that the patient was not presenting before the ingest.The hcp also said that the patient's mother informed that her daughter has many kind of allergies (not specified).

• 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: 5959320
• MDR Text Key: 55003202
• Report Number: 1020379-2016-00041
• 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: 08/11/2016

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: 08/11/2016
• Initial Date FDA Received: 09/19/2016
• 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: 2 YR