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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Choking (2464)
Event Date 06/13/2017
Event Type  Injury  
Manufacturer Narrative
This report is associated with argus case (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
Choking [choking].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) male patient who received double salt denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for denture wearer.Concurrent medical conditions included denture wearer.On (b)(6) 2017, the patient started japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 (oral) 1 dosage form(s) single dose (1 dosage form(s) daily).On (b)(6) 2017, 0 min after starting japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced choking (serious criteria gsk medically significant) 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 choking and accidental ingestion of product were unknown.It was unknown if the reporter considered the choking to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.[clinical course] on (b)(6) 2016, the patient accidentally ate a whole tablet of japanese 5 minute polident (enzyme with sodium percarbonate).Subsequently, he had some water.He choked a little.
 
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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.
2149 harbor avenue
memphis TN 38113
Manufacturer (Section G)
GSK
Manufacturer Contact
po box 13398
research triangle park, NC 27709
8888255249
MDR Report Key6653149
MDR Text Key78020198
Report Number1020379-2017-00049
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial
Report Date 06/13/2017
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 06/13/2017
Initial Date FDA Received06/20/2017
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 Number1
Patient Outcome(s) Other;
Patient Age92 YR
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