MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Mdr 1020379-2018-00046 is associated with argus case (b)(4), polident denture cleanser.

Event Description

Medication error- ate accidently (accidental device ingestion); discomfort.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 denture cleanser (polident denture cleanser) tablet for product used for unknown indication.Concurrent medical conditions included dementia.On an unknown date, the patient started polident denture cleanser.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and discomfort.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion was not reported and the outcome of the discomfort was recovered/resolved.It was unknown if the reporter considered the accidental device ingestion and discomfort to be related to polident denture cleanser.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the consumer reported that patient ate one tablet of polident denture cleanser accidentally because patient thought it was a candy (maybe due to dementia).The patient had discomfort at that time, and the reporter let patient drink more water.The patient did not see the doctor at that time.The patient's condition and diet were normal in recent days (1 to 2 days) under the reporter's observation.The patient did not have discomfort now.

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7797807
• MDR Text Key: 117615623
• Report Number: 1020379-2018-00046
• 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: 08/10/2018

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: 08/10/2018
• Initial Date FDA Received: 08/20/2018
• 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