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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Glossodynia [glossodynia].Case description: this case was reported by a consumer via call center representative and described the occurrence of glossodynia in a 84-year-old female patient who received denture cleanser (japanese 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 japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 (other) at an unknown dose and frequency.On an unknown date, an unknown time after starting japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced glossodynia (serious criteria hospitalization).The action taken with japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 was unknown.On an unknown date, the outcome of the glossodynia was unknown.It was unknown if the reporter considered the glossodynia to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.[clinical course]: on an unknown date, the patient, the reporter's mother, used japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On an unknown date, allegedly, the patient did not agree with peppermint; it caused her glossodynia.An oral gel that had been given to her at a dental clinic seemed to contain peppermint, and although she stopped using the gel, the pain did not resolve.The pain in her tongue reached its maximum level, resulting in hospitalization (serious criteria hospitalization).No further information is expected.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC; memphis TN
• Manufacturer Contact: 184 liberty corner road,; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 17918349
• MDR Text Key: 325445636
• Report Number: 1020379-2023-00034
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/12/2023
• 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: 84 YR
• Patient Sex: Female