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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Choking (2464)

Event Type  Death  

Manufacturer Narrative

# 1020379-2018-00044 is associated with (b)(4), polident denture cleanser.

Event Description

Choked [choking].Case description: this case was reported by a other health professional via sales rep and described the occurrence of choking in a patient who received denture cleanser (polident denture cleanser) tablet for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced choking (serious criteria death and gsk medically significant), accidental ingestion of product and product complaint.On an unknown date, the outcome of the choking was fatal and the outcome of the accidental ingestion of product and product complaint were unknown.The reported cause of death was choking.The reporter considered the choking to be related to polident denture cleanser.Additional details: a hygienist reported that she was recently told by a carer at an aged care facility, that one of their elderly patients (a couple of years prior) had accidentally ingested a cleanser tablet, believed it to be a mint, and as a result had choked on the tablet and died as a result.Follow up would not be conducted as the reporter had not provided consent.

Manufacturer Narrative

1020379-2018-00044 is associated with argus case (b)(4), polident denture cleanser.Investigation summary for complaint (b)(4); 13 august 2018: all polident products are consistently manufactured and packaged per a standard process to ensure the consistent manufacture of product meeting the packaged finished product specifications (pfps).There are manual in-process quality checks performed throughout the entire process to ensure the consistent manufacture and packaging of product in accordance with the pfps.All lots are tested against pfps and reviewed prior to release as part of the routine batch disposition process.Polident tablets are specially formulated to remove stains from dentures and control denture odors.All ingredients used in the manufacture of polident are fda approved to be safe and effective for the intended use.The product should be used as instructed on the carton directions.The polident display carton contains specific caution instructions for consumers.Caution statements specific to ingestion include picture representation of the accompanying text that reads: polident tablets are specially formulated to remove stains from dentures and control denture odors.All ingredients used in the manufacture of polident are fda approved to be safe and effective for the intended use.The product should be used as instructed on the carton directions.The polident display carton contains specific caution instructions for consumers.Caution statements specific to ingestion include picture representation of the accompanying text that reads: keep tablets out of reach of children and those who are at risk of accidentally swallowing the tablet or solution.Keep tablet solution out of mouth.Do not drink cleansing solution or use as a mouthwash.Do not place tablets in mouth.Rinse well.Based on the complaint being associated with use of the product beyond the intended use and in conflict with product packaging use instructions and specific caution statements, this complaint is determined to be unsubstantiated as a product safety issue related to the product when used as intended.Long term trending for most recent 24 month signal analysis (jul2016 through jun2018).Was reviewed for the complaint reason subject to this complaint issue.No actionable trend was identified.Therefore, there is no evidence of a current trend indicating the need to expand the investigation to the product family.The scope is limited to this complaint case.

Event Description

Case description: this case was reported by a other health professional via sales rep and described the occurrence of choking in a patient who received denture cleanser (polident denture cleanser) tablet for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced choking (serious criteria death and gsk medically significant), accidental ingestion of product and product complaint.On an unknown date, the outcome of the choking was fatal and the outcome of the accidental ingestion of product and product complaint were unknown.The reported cause of death was choking.The reporter considered the choking to be related to polident denture cleanser.Additional details: a hygienist reported that she was recently told by a carer at an aged care facility, that one of their elderly patients (a couple of years prior) had accidentally ingested a cleanser tablet, believed it to be a mint, and as a result had choked on the tablet and died as a result.Follow up would not be conducted as the reporter had not provided consent.Follow up was received from quality assurance department on 13 aug 2018.Quality assurance analysis revealed the complaint to be unsubstantiated.

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 7782558
• MDR Text Key: 117118655
• Report Number: 1020379-2018-00044
• 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: 08/09/2018

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: No
• 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