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

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I started choking.I started gagging from the ammonia.Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a 57-year-old male patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unknown, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident overnight denture cleanser tablets.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced choking (serious criteria haleon medically significant), gagging, wrong technique by user in product cleaning and product complaint.The action taken with polident overnight denture cleanser tablets was unknown.On an unknown date, the outcome of the choking and gagging were recovered/resolved and the outcome of the wrong technique by user in product cleaning and product complaint were unknown.It was unknown if the reporter considered the choking and gagging to be related to polident overnight denture cleanser tablets.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details:adverse event information was received by consumer via call center representative (phone) on (b)(6) 2023.The consumer reported, "calling about possible contamination denture overnight.It smelled and tasted like ammonia.I tried one more tablet in a glass of water and it smelled the same.I though it was something in the house.I walked in the morning i started gaging and chocking from the ammonia.They were still having the same smell after 2 hours.I used soap to try to clean them.Still getting minor taste but a lot less.I was told by the dentist to give you a call.I talked to the poison control on the evening after.They said that there was lot numbers on the tablets.I threw away the box.".

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road, suite 20; warren, NJ 07059 ; 8888255249
• MDR Report Key: 17753974
• MDR Text Key: 323467711
• Report Number: 1020379-2023-00031
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/15/2023
• 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): Other
• Patient Age: 57 YR
• Patient Sex: Male