• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC5625; DENTURE CLEANSER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLOCK DRUG CO., INC. JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC5625; DENTURE CLEANSER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/18/2023
Event Type  Injury  
Manufacturer Narrative
Argus case: (b)(4).
 
Event Description
Hospitalisation [hospitalisation].Case description: this case was reported by a consumer via call center representative and described the occurrence of hospitalisation in a patient who received denture cleanser (japanese polident for partials(with sodium percarbonate)-mfc5625) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started japanese polident for partials (with sodium percarbonate)-mfc5625.On (b)(6) 2023, an unknown time after starting japanese polident for partials(with sodium percarbonate)-mfc5625, the patient experienced hospitalisation (serious criteria hospitalization).The action taken with japanese polident for partials(with sodium percarbonate)-mfc5625 was unknown.On an unknown date, the outcome of the hospitalisation was unknown.It was unknown if the reporter considered the hospitalisation to be related to japanese polident for partials(with sodium percarbonate)-mfc5625.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on an unknown date, the patient, the reporter's family member, used japanese polident for partials(with sodium percarbonate)-mfc5625.On (b)(6) 2023, the patient experienced urgent hospitalisation (serious criteria hospitalization).No further information is expected.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC5625
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 Key18158438
MDR Text Key328355844
Report Number1020379-2023-00036
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 11/06/2023
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 11/06/2023
Initial Date FDA Received11/17/2023
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;
-
-