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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Erythema (1840); Overdose (1988); Coma (2417); Loss of consciousness (2418)

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

1020379-2016-00001 is associated with (b)(4) japanese 5 minute polident (enzyme with taed).

Event Description

Coma.Suicide attempt.Bradycardia.Erythema.Intentional overdose.Case description: this case was reported by a physician via out of hour services and described the occurrence of coma in a (b)(6) female patient who received double salt denture cleanser (japanese 5 minute polident (enzyme with taed)) tablet for an unknown indication.Concomitant products included medication unknown (unknown drug).On an unknown date, the patient started japanese 5 minute polident (enzyme with taed).On (b)(6) 2016, unknown after starting japanese 5 minute polident (enzyme with taed), the patient experienced coma (serious criteria gsk medically significant), bradycardia and erythema.On (b)(6) 2016 19:00, the patient experienced intentional overdose.On an unknown date, the patient experienced suicide attempt (serious criteria gsk medically significant).On an unknown date, the outcome of the coma, suicide attempt, bradycardia, erythema and intentional overdose were unknown.It was not reported if the reporter considered the coma, suicide attempt, bradycardia and erythema to be related to japanese 5 minute polident (enzyme with taed).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Concomitant product: hypnotic sedative and anti-anxiety drug (for medical use) (unknown drug).On (b)(6) 2016 [at 19:00] the patient was found.The patient was found lying unconscious by her family member, and was taken to the reporter's hospital.There were notes by her bedside, and approximately 10 packages of japanese 5 minute polident (enzyme with taed) had been thrown in a trash can.No emergency care was performed.On (b)(6) 2016: [at 19:30] the patient was seen in the medical institution, and was treated with infusion.Case comment: no empty packages were found, but the patient might take an overdose of the drug.

Manufacturer Narrative

Report 1020379-2016-00001 is associated with (b)(4) (b)(6) 5 minute polident (enzyme with taed).

Event Description

Coma [coma].Suicide attempt [suicide attempt].Bradycardia [bradycardia].Erythema [erythema].Altered state of consciousness [consciousness disturbed].Infection [infection].Intentional overdose [intentional overdose].Case description: this case was reported by a physician via out of hour services and described the occurrence of coma in a (b)(6) female patient who received double salt denture cleanser ((b)(6) 5 minute polident (enzyme with taed)) tablet for an unknown indication.Concomitant products included medication unknown (unknown drug).On an unknown date, the patient started (b)(6) 5 minute polident (enzyme with taed).On (b)(6) 2016, unknown after starting (b)(6) 5 minute polident (enzyme with taed), the patient experienced coma (serious criteria gsk medically significant and other: serious adverse event), bradycardia (serious criteria gsk medically significant) and erythema (serious criteria other: serious adverse event).On (b)(6) 2016 19:00, the patient experienced intentional overdose.On an unknown date, the patient experienced suicide attempt (serious criteria gsk medically significant and other: serious adverse event), consciousness disturbed (serious criteria hospitalization and gsk medically significant) and infection (serious criteria hospitalization).On an unknown date, the outcome of the coma, suicide attempt, bradycardia, erythema, consciousness disturbed, infection and intentional overdose were unknown.It was not reported if the reporter considered the coma, suicide attempt, bradycardia, erythema, consciousness disturbed and infection to be related to (b)(6) 5 minute polident (enzyme with taed).Concomitant product: hypnotic sedative and anti-anxiety drug (for medical use) (unknown drug).On (b)(6) 2016 [at 19:00] the patient was found.The patient was found lying unconscious by her family member, and was taken to the reporter's hospital.There were notes by her bedside, and approximately 10 packages of (b)(6) 5 minute polident (enzyme with taed) had been thrown in a trash can.No emergency care was performed.On (b)(6) 2016: [at 19:30] the patient was seen in the medical institution, and was treated with infusion.Follow-up information received from the reporting physician on 05 july 2016 [clinical course]: the patient intentionally overdosed herself with drugs, which was evident in a trash bag containing empty packages of prescription drugs and about 10 bags of (b)(6) 5 minute polident (enzyme with taed).She was admitted to the hospital for nine days due to infection that occurred concurrently.

Manufacturer Narrative

Report 1020379-2016-00001 is associated with (b)(4) 5 minute polident (enzyme with taed).

Event Description

Case description: this case was reported by a physician via out of hour services and described the occurrence of coma in a (b)(6) female patient who received double salt denture cleanser ((b)(6) 5 minute polident (enzyme with taed)) tablet for an unknown indication.Concomitant products included medication unknown (unknown drug).On an unknown date, the patient started (b)(6) 5 minute polident (enzyme with taed).On (b)(6) 2016, unknown after starting (b)(6) 5 minute polident (enzyme with taed), the patient experienced coma (serious criteria gsk medically significant and other: serious adverse event), bradycardia (serious criteria gsk medically significant) and erythema (serious criteria other: serious adverse event).On (b)(6) 2016 19:00, the patient experienced intentional overdose.On an unknown date, the patient experienced suicide attempt (serious criteria gsk medically significant and other: serious adverse event), consciousness disturbed (serious criteria hospitalization and gsk medically significant) and infection (serious criteria hospitalization).On an unknown date, the outcome of the coma, suicide attempt, bradycardia, erythema, consciousness disturbed, infection and intentional overdose were unknown.It was not reported if the reporter considered the coma, suicide attempt, bradycardia, erythema, consciousness disturbed and infection to be related to (b)(6) 5 minute polident (enzyme with taed).Concomitant product: hypnotic sedative and anti-anxiety drug (for medical use) (unknown drug).On (b)(6) 2016 [at 19:00] the patient was found.The patient was found lying unconscious by her family member, and was taken to the reporter's hospital.There were notes by her bedside, and approximately 10 packages of (b)(6) 5 minute polident (enzyme with taed) had been thrown in a trash can.No emergency care was performed.On (b)(6) 2016: [at 19:30] the patient was seen in the medical institution, and was treated with infusion.Follow-up information received from the reporting physician on 05 july 2016 [clinical course]: the patient intentionally overdosed herself with drugs, which was evident in a trash bag containing empty packages of prescription drugs and about 10 bags of (b)(6) 5 minute polident (enzyme with taed).She was admitted to the hospital for nine days due to infection that occurred concurrently.Follow-up information received from the reporting physician on 13 july 2016.[clinical course]: since no one witnessed the patient swallowing (b)(6) 5 minute polident, her symptoms could not be regarded as drug poisoning.

• Brand Name: JAPANESE 5 MINUTE POLIDENT (ENZYME WITH TAED)
• 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: 5383225
• MDR Text Key: 36594254
• Report Number: 1020379-2016-00001
• 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,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2016

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: 01/14/2016
• Initial Date FDA Received: 01/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/11/2016; 07/21/2016
• 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; Other
• Patient Age: 87 YR
• Patient Weight: 50