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

Lot Number MI2817136

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burning Sensation (2146); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Mfr report 1020379-2018-00050 is associated with argus case (b)(4), polident smokers denture cleanser tablets.

Event Description

I swallow some of this every day [accidental device ingestion].I started experiencing burning in my mouth [burning mouth].I only use part of the tablet and put it in there.I rinse for a week straight [wrong technique in device usage process].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) male patient who received denture cleanser (polident smokers denture cleanser tablets) tablet (batch number mi2817136, expiry date unknown) for dental care.On an unknown date, the patient started polident smokers denture cleanser tablets (dental) at an unknown dose and frequency.On an unknown date, an unknown time after starting polident smokers denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant), burning mouth and wrong technique in device usage process.Polident smokers denture cleanser tablets was discontinued on (b)(6) 2018 (dechallenge was negative).On an unknown date, the outcome of the accidental device ingestion and wrong technique in device usage process were unknown and the outcome of the burning mouth was not recovered/not resolved.The reporter considered the accidental device ingestion and burning mouth to be related to polident smokers denture cleanser tablets.It was unknown if the reporter considered the wrong technique in device usage process to be related to polident smokers denture cleanser tablets.Additional details, adverse event information was received on 22 august 2018.Consumer reported that "i am calling about polident smokers.The tablets you put in the water to clean your dentures.When i started experiencing burning in my mouth i only use part of the tablet and put it in there.It says to rinse with running water.I rinse for a week straight.I have been using this for 3 years on and off when i can afford it.This is burning my mouth continually.I have not used it in a week or so.I have been using a natural solution.I cant walk outside with my dentures, i am incapable of doing it.I swallow some of this every day.It is embedded into my denture.How can i stop the burning? i have to set up an appointment 60 miles away because i don't have dental care.I will have to wait a month for new dentures.It burns so bad.I don't even smoke cigarettes.I was using a fluoride toothpaste and switched to a fluoride free toothpaste.When i was using the fluoride toothpaste it was burning my mouth.It burns all day long.Last time i used it a was a week ago.I was hoping i could call you and you can tell me information".Co-suspect product included "unspecified fluoride toothpaste".The reporter considered the burning mouth to be related to unspecified fluoride toothpaste.

• Brand Name: POLIDENT SMOKERS DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7825519
• MDR Text Key: 118550494
• Report Number: 1020379-2018-00050
• 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: 08/22/2018

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?: No
• Device Operator: Lay User/Patient
• Device Lot Number: MI2817136
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 08/28/2018
• 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): Other
• Patient Age: 28 YR