MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009; DENTURE CLEANSER

Device Problem Off-Label Use (1494)

Patient Problem Irritation (1941)

Event Date 10/30/2016

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), (b)(6) 5 minute polident.(b)(6) 5 minute polident is marketed as polident tablets in the us.

Event Description

Throat irritation [pharynx irritated sensation of].Case description: this case was reported by a non-health professional via out of hour services and described the occurrence of pharynx irritated sensation of in a (b)(6) male patient who received double salt denture cleanser ((b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On (b)(6) 2016, unknown after starting (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced pharynx irritated sensation of (serious criteria hospitalization).On an unknown date, the patient experienced accidental ingestion of product.The action taken with (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009 was unknown.On an unknown date, the outcome of the pharynx irritated sensation of was recovering/resolving and the outcome of the accidental ingestion of product was unknown.It was unknown if the reporter considered the pharynx irritated sensation of to be related to (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009.[clinical course]: the elderly patient, who had ingested the denture cleanser by mistaking it for a medicine, presented to the reporter's hospital.He had irritation in the throat but showed an improvement tendency.No treatment was given for the event.Follow-up information received from (b)(6) poison information center on 06 january 2017.[clinical course]: on (b)(6) 2016, at 23:30, the patient ingested the denture cleanser one tablet by mistaking it for a medicine.The patient did not have dementia and it was unknown why he ingested.On (b)(6) 2016, the patient visited a hospital.In consideration for the age and symptom, the patient was hospitalized for one day for observation.

• Brand Name: JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009
• 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: 6256052
• MDR Text Key: 64930526
• Report Number: 1020379-2017-00002
• 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
• Type of Report: Initial
• Report Date: 10/31/2016

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: No Information
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/17/2017
• 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): Hospitalization
• Patient Age: 88 YR
• Patient Weight: 61