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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Overdose (1988)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), polident overnight denture cleanser tablets.

Event Description

His co-worker had swallowed 5 to 6 of the polident overnight whitening tablets [accidental device ingestion] his co-worker had swallowed 5 to 6 of the polident overnight whitening tablets.[accidental overdose] case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a male patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unk, expiry date unknown) for drug use for unknown indication.On an unknown date, the patient started polident overnight denture cleanser tablets at an unknown dose and frequency.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) and accidental overdose.On an unknown date, the outcome of the accidental device ingestion and accidental overdose were unknown.It was unknown if the reporter considered the accidental device ingestion and accidental overdose to be related to polident overnight denture cleanser tablets.Additional information adverse event information was received on 30 january 2018.Consumer called in and stated that his co-worker had swallowed 5 to 6 of the polident overnight whitening tablets and did not know what he should tell his co-worker to do.

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLENASER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 7274253
• MDR Text Key: 100197607
• Report Number: 1020379-2018-00011
• 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
• Report Date: 01/30/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/15/2018
• 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