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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Vomiting (2144); Reaction (2414)

Event Date 08/12/2017

Event Type  Death  

Manufacturer Narrative

Mdr 1020379-2017-00084 is associated with argus case(b)(4), (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009.(b)(6) 5 minute polident is marketed as polident tablets in the us.

Event Description

Intestinal ischaemia [non-occlusive mesenteric ischaemia].Cardiac arrest [cardiac arrest].Enterocolitis [enterocolitis].Vomiting [vomiting].Abdominal pain [abdominal pain].Blood pressure decreased [blood pressure decreased].Case description: this case was reported by a other health professional via other manufacturer and described the occurrence of non-occlusive mesenteric ischaemia in a (b)(6) female patient who received double salt denture cleanser ((b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for an unknown indication.Concurrent medical conditions included dementia and living in residential institution.On (b)(6) 2017, the patient started (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009 (oral) at an unknown dose and frequency.On (b)(6) 2017, 0 min after starting (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced enterocolitis (serious criteria gsk medically significant), vomiting, abdominal pain and accidental ingestion of product.On (b)(6) 2017, the patient experienced cardiac arrest (serious criteria gsk medically significant) and blood pressure decreased.In (b)(6) 2017, the patient experienced non-occlusive mesenteric ischaemia (serious criteria death and gsk medically significant).On (b)(6) 2017, the outcome of the non-occlusive mesenteric ischaemia was fatal.On an unknown date, the outcome of the cardiac arrest, enterocolitis, vomiting, abdominal pain, blood pressure decreased and accidental ingestion of product were unknown.The patient died on (b)(6) 2017.The reported cause of death was non-occlusive mesenteric ischaemia.It was unknown if the reporter considered the non-occlusive mesenteric ischaemia, cardiac arrest, enterocolitis, vomiting, abdominal pain and blood pressure decreased to be related to (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009.[clinical course].On (b)(6) 2017, at 8:30, the patient with dementia probably ingested one tablet of (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009.She vomited three times, and then, complained of abdominal pain.No first aid was given.She consulted a physician on the same day.Details of treatment were unknown.Follow-up information received from (b)(6) poison information center on (b)(6) 2017 [clinical course].On (b)(6) 2017, the patient with dementia living in residential institution vomited in large amounts and complained of abdominal pain.Two moist packets of (b)(6) 5 minute polident (enzyme with sodium percarbonate)-mfc51009 were left at bedside and accidental ingestion was suspected.Enteritis was suspected in the result of computed tomography (ct).She was treated with transfusion and analgesic agent.On (b)(6) 2017, blood pressure decreased and cardiac arrest occurred.On the second day from the accidental ingestion, she died of non-occlusive mesenteric ischemia.

Manufacturer Narrative

Mfr report 1020379-2017-00084 is associated with argus case (b)(4), (b)(6) 5 minute polident (enzyme with sodium percarbonate)-(b)(6).5 minute polident is marketed as polident tablets in the us.

Event Description

Case description: this case was reported by a other health professional via other manufacturer and described the occurrence of non-occlusive mesenteric ischaemia in a (b)(6) female patient who received double salt denture cleanser ((b)(6) 5 minute polident (enzyme with sodium percarbonate) (b)(6) ) tablet for an unknown indication.Concurrent medical conditions included dementia and living in residential institution.On (b)(6) 2017, the patient started (b)(6) 5 minute polident (enzyme with sodium percarbonate)-(b)(4) (oral) at an unknown dose and frequency.On (b)(6) 2017, 0 min after starting (b)(6) 5 minute polident (enzyme with sodium percarbonate)-(b)(4), the patient experienced enterocolitis (serious criteria gsk medically significant), vomiting, abdominal pain and accidental ingestion of product.On (b)(4) 2017, the patient experienced cardiac arrest (serious criteria gsk medically significant) and blood pressure decreased.In (b)(6) 2017, the patient experienced non-occlusive mesenteric ischaemia (serious criteria death and gsk medically significant).On (b)(6) 2017, the outcome of the non-occlusive mesenteric ischaemia was fatal.On an unknown date, the outcome of the cardiac arrest, enterocolitis, vomiting, abdominal pain, blood pressure decreased and accidental ingestion of product were unknown.The patient died on (b)(6).The reported cause of death was non-occlusive mesenteric ischaemia.It was unknown if the reporter considered the non-occlusive mesenteric ischaemia, cardiac arrest, enterocolitis, vomiting, abdominal pain and blood pressure decreased to be related to (b)(6) 5 minute polident (enzyme with sodium percarbonate)-(b)(4).Clinical course- on (b)(6) 2017, at 8:30, the patient with dementia probably ingested one tablet of (b)(6) 5 minute polident (enzyme with sodium percarbonate)-(b)(6).She vomited three times, and then, complained of abdominal pain.No first aid was given.She consulted a physician on the same day.Details of treatment were unknown.Follow-up information received from japan poison information center on (b)(6) 2017 clinical course on (b)(6) 2017, the patient with dementia living in residential institution vomited in large amounts and complained of abdominal pain.Two moist packets of (b)(6) 5 minute polident (enzyme with sodium percarbonate)-(b)(6) were left at bedside and accidental ingestion was suspected.Enteritis was suspected in the result of computed tomography (ct).She was treated with transfusion and analgesic agent.On (b)(6) 2017, blood pressure decreased and cardiac arrest occurred.On the second day from the accidental ingestion, she died of non-occlusive mesenteric ischemia.Follow-up information received from (b)(6) poison information center on (b)(6) 2017 reporter's comment.The attending was uncertain about the relation with the accidental ingestion of (b)(6) 5 minute polident (enzyme with sodium percarbonate)-(b)(6).

• 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: 7143824
• MDR Text Key: 95691492
• Report Number: 1020379-2017-00084
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/02/2018
• 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): Death; Other
• Patient Age: 96 YR
• Patient Weight: 45