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

Lot Number MB231814F

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

Mdr 1020379-2018-00047 is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

I wrongly drank some polident denture cleanser because it looked like a cup of water.(accidental device ingestion).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 overnight denture cleanser tablets) tablet (batch number mb231814f, expiry date unknown) for denture wearer.On (b)(6) 2018, 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 accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident overnight denture cleanser tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information, adverse event information was received via call on 13 august 2018.Consumer reported that, "i wrongly drank some polident denture cleanser because it looked like a cup of water.I want to know what is going to happen to me?".

Event Description

Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a 68-year-old male patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number mb231814f, expiry date unknown) for denture wearer.On (b)(6) 2018, 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 accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident overnight denture cleanser tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information, adverse event information was received via call on 13 august 2018.Consumer reported that, "i wrongly drank some polident denture cleanser because it looked like a cup of water.I want to know what is going to happen to me?" follow up information was received on 11 october 2018 via returned consumer authorization form.Consumer reported that, "i accidentally took only two sips of polident (dissolved in a cup of water).I did not experience any reactions from the dissolved polident and did not report the incident to my primary care physician (pcp) or other health care provider.Consumer had not provided physicians information.

Manufacturer Narrative

1020379-2018-00047 is associated with argus case us2018147124, polident overnight denture cleanser tablets.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 7798522
• MDR Text Key: 117697261
• Report Number: 1020379-2018-00047
• 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
• Type of Report: Initial,Followup
• Report Date: 08/13/2018

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: MB231814F
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR