MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DOUBLE POWER; DENTURE CLEANSER

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

Patient Problems Loss of consciousness (2418); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Foaming at mouth; loss of consciousness.Case description: this case was reported by a pharmacist via call center representative, and described the occurrence of accidental ingestion of product in a unk patient who received denture cleanser (polident double power) tablet (batch number unk, expiry date unknown) for an unknown indication.On an unknown date, the patient started polident double power (oral) at an unknown dose and frequency.On an unknown date, an unknown time after starting polident double power, the patient experienced accidental ingestion of product.The action taken with polident double power was unknown.On an unknown date, the outcome of the accidental ingestion of product was unknown.Clinical course: on an unknown date, the patient was transported to a hospital after accidentally taking 13 tablets of polident double power.Follow-up information received from the reporting pharmacist via sales rep on 21 october 2020.[clinical course] concurrent medical conditions included living in residential institution and dementia.On an unknown date, the patient with dementia living in a residential institution experienced foaming at mouth and loss of consciousness (serious criteria gsk medically significant) after accidentally taking 13 tablets of polident double power.The patient was transported to a general hospital.Details were unknown at present because it was hard to contact to icu due to covid-19.The patient's family calculated the number of tablets of polident double power as 13 from the remained ones.It was unknown if the patient actually took 13 tablets.On an unknown date, the outcome of the foaming at mouth and loss of consciousness were unknown.Reporter's comment: it was unknown if the reporter considered the foaming at mouth and loss of consciousness to be related to polident double power.

Event Description

Case description: this case was reported by a pharmacist via call center representative and described the occurrence of accidental ingestion of product in a unk patient who received denture cleanser (polident double power) tablet (batch number unk, expiry date unknown) for an unknown indication.On an unknown date, the patient started polident double power (oral) at an unknown dose and frequency.On an unknown date, an unknown time after starting polident double power, the patient experienced accidental ingestion of product.The action taken with polident double power was unknown.On an unknown date, the outcome of the accidental ingestion of product was unknown.Clinical course: on an unknown date, the patient was transported to a hospital after accidentally taking 13 tablets of polident double power.Follow-up information received from the reporting pharmacist via sales rep on 21 october 2020 clinical course: concurrent medical conditions included living in residential institution and dementia.On an unknown date, the patient with dementia living in a residential institution experienced foaming at mouth and loss of consciousness (serious criteria gsk medically significant) after accidentally taking 13 tablets of polident double power.The patient was transported to a general hospital.Details were unknown at present because it was hard to contact to icu due to covid-19.The patient's family calculated the number of tablets of polident double power as 13 from the remained ones.It was unknown if the patient actually took 13 tablets.On an unknown date, the outcome of the foaming at mouth and loss of consciousness were unknown.Reporter's comment: it was unknown if the reporter considered the foaming at mouth and loss of consciousness to be related to polident double power.Follow-up information received from the reporting pharmacist via medical representative on 14 january 2021 clinical course: on an unknown date, the patient experienced foaming at mouth and loss of consciousness (serious criteria death and gsk medically significant).On an unknown date, the outcome of the foaming at mouth and loss of consciousness were fatal.Reporter's comment: the reporter considered the foaming at mouth and loss of consciousness to be unrelated to polident double power.Pharmacist: unrelated.Physician: unrelated.No further information will be provided due to the refusal of the reporting pharmacist.Downgrade report.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: POLIDENT DOUBLE POWER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis; TN
• MDR Report Key: 10822666
• MDR Text Key: 216103879
• Report Number: 1020379-2020-00056
• 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: 10/21/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other