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 No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), corega tabs 3 minuten.Corega tabs 3 minuten is marketed as polident tablets in the us.

Event Description

Incorrect administration of tablets/possible medication error [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 elderly patient who received double salt denture cleanser (corega tabs 3 minuten) tablet for denture wearer.On an unknown date, the patient started corega tabs 3 minuten.On an unknown date, an unknown time after starting corega tabs 3 minuten, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with corega tabs 3 minuten was unknown.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: event received from employee at pharmacy customer service via call center.We do not know whether the reporter is hcp or not.A relative of a patient has contacted the pharmacy customer service to ask for advice regarding an elderly family member who might have swallowed corega dental cleanser effervescent tablets.Relatives monitored the patient afterwards, but patient did not get any symptoms.

• Brand Name: COREGA TABS 3 MINUTEN
• 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: 7083896
• MDR Text Key: 93760962
• Report Number: 1020379-2017-00078
• 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: 11/24/2017

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: 11/24/2017
• Initial Date FDA Received: 12/05/2017
• 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