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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Discomfort (2330)

Event Date 10/30/2016

Event Type  Injury  

Manufacturer Narrative

Tis report is associated with argus case (b)(4).(b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009 is marketed as polident tablets in the us.

Event Description

Oropharyngeal discomfort.Case description: this case was reported by a consumer via out of hour services and described the occurrence of oropharyngeal discomfort in a (b)(6) male patient who received double salt denture cleanser ((b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for denture wearer.Concurrent medical conditions included denture wearer and headache.On an unknown date, the patient started (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On (b)(6) 2016, unknown after starting (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced oropharyngeal discomfort (serious criteria hospitalization).On an unknown date, the patient experienced accidental ingestion of product.The action taken with (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009 was unknown.On (b)(6) 2016, the outcome of the oropharyngeal discomfort was recovered/resolved.On an unknown date, the outcome of the accidental ingestion of product was unknown.It was unknown if the reporter considered the oropharyngeal discomfort to be related to (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009.[clinical course] on (b)(6) 2016, the elderly patient accidentally ingested 1 tablet of (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009 at 23:10.The tablet seemed to have gotten stuck in the throat.The patient had no dementia and the cause of the incident was unknown.Follow-up information received from (b)(6) poison information center on 29 november 2016.[clinical course] at 23:10 on (b)(6) 2016, the patient tried to take a medication for his headache after washing his face, but ingested instead the tablet of (b)(6) 5 minute polident (enzyme with taed) he then happened to have in his hand.The polident tablet got stuck in his throat.By the time he presented to the hospital that night, his symptom subsided.He was admitted there overnight to receive a drip infusion.In the following morning on (b)(6) 2016, he was discharged home.

• 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: 6149064
• MDR Text Key: 61556392
• Report Number: 1020379-2016-00068
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 10/30/2016

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: 11/29/2016
• Initial Date FDA Received: 12/06/2016
• 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: 88 YR
• Patient Weight: 62