MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE TABLETS; DENTURE CLEANSER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Chemical Exposure (2570)

Event Type  Injury  

Manufacturer Narrative

1020379-2018-00054 is associated with (b)(4), polident 3 minute tablets.

Event Description

I accidentally drank some of the solution where the polident 3 minute tablet had dissolved [accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received denture cleanser (polident 3 minute tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On (b)(6) 2018, the patient started polident 3 minute tablets.On an unknown date, an unknown time after starting polident 3 minute 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 3 minute 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 (b)(6) 2018.The consumer reported that, "i accidentally drank some of the solution where the polident 3 minute tablet had dissolved.It wasn't a huge amount.Is it safe?".

• Brand Name: POLIDENT 3 MINUTE 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: 7838627
• MDR Text Key: 119025930
• Report Number: 1020379-2018-00054
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 08/21/2018
• 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: 92 YR