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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bradycardia (1751); Alteration In Body Temperature (2682)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.Japanese 5 minute polident is marketed as polident tablets in the us.

Event Description

Bradycardia [bradycardia].Body temperature decreased [body temperature decreased].Case description: this case was reported by a other health professional via other manufacturer and described the occurrence of bradycardia in a (b)(6) female patient who received double salt denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for an unknown indication.Concurrent medical conditions included diabetes mellitus, dementia and living in residential institution.On an unknown date, the patient started japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On (b)(6) 2017, less than a day after starting japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced bradycardia (serious criteria gsk medically significant), body temperature decreased and accidental ingestion of product.The action taken with japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 was unknown.On an unknown date, the outcome of the bradycardia, body temperature decreased and accidental ingestion of product were unknown.It was unknown if the reporter considered the bradycardia and body temperature decreased to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on (b)(6) 2017, at 6:15, the patient with dementia accidentally ingested 2.5 tablets of japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 and visited the reporting medical institution.Bradycardia and decreased body temperature were noted.Dilution was conduction as a first-aid.

• 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: 7037541
• MDR Text Key: 92304849
• Report Number: 1020379-2017-00077
• 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: 11/07/2017

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: No Information
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/16/2017
• 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
• Patient Age: 92 YR
• Patient Weight: 53