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 Problems Vomiting (2144); Ulcer (2274); Discomfort (2330)

Event Date 03/24/2017

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus (b)(4), japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.Japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 is marketed as polident in the us.

Event Description

Gastric ulcer, abdominal discomfort, vomiting.Case description: this case was reported by a non-health professional via out of hour services and described the occurrence of gastric ulcer in a (b)(6) female patient who received double salt denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for an unknown indication.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 abdominal discomfort (serious criteria hospitalization), vomiting and accidental ingestion of product.On an unknown date, the patient experienced gastric ulcer (serious criteria hospitalization and gsk medically significant).The action taken with japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 was unknown.On (b)(6) 2017, the outcome of the vomiting was recovering/resolving.On (b)(6) 2017, the outcome of the abdominal discomfort was recovering/resolving.On an unknown date, the outcome of the gastric ulcer and accidental ingestion of product were unknown.It was unknown if the reporter considered the gastric ulcer, abdominal discomfort and vomiting to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On (b)(6) 2017, at night, the patient ingested one tablet of japanese 5 minute polident (enzyme with sodium percarbonate) at home.When she made an emergency call, she was told to drink milk and see her clinical course.Emergency action taken: dilution.On (b)(6) 2017, she felt a strange abdominal sensation.On (b)(6) 2017, she presented to the hospital.Treatment given at the hospital: unknown.Follow-up information received from japan poison information center on 20 april 2017.On (b)(6) 2017, the patient was half asleep at night and accidentally ingested 1 tablet of japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.After taking some milk, she vomited and complained of stomach discomfort.On (b)(6) 2017, she consulted a hospital and gastric ulcer was revealed by endoscopy.She received transfusion.She was hospitalized for six days as of (b)(6) 2017.Follow-up information received from japan poison information center on 27 april 2017.No vomiting was noted on the second day of the event.No stomach discomfort was noted at the restart of meal on the fourth day.The outcome of gastric ulcer was unknown because the patient was discharged from the hospital on the seventh day and she was followed up on an outpatient basis.

• 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: 6537271
• MDR Text Key: 74207907
• Report Number: 1020379-2017-00034
• 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: foreign
• Type of Report: Initial
• Report Date: 03/25/2017

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: 04/20/2017
• Initial Date FDA Received: 05/02/2017
• 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 Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR
• Patient Weight: 50