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U.S. Department of Health and Human Services

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

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BLOCK DRUG CO., INC JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009; DENTURE CLEANSER Back to Search Results
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).
 
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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 Key17918349
MDR Text Key325445636
Report Number1020379-2023-00034
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received10/12/2023
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 Number1
Patient Outcome(s) Hospitalization;
Patient Age84 YR
Patient SexFemale
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