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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Polident overnight-i cut one the tablets in half and i put it inside of the water and i drank a little bit of it in the morning without realizing what it was [accidental device ingestion] polident overnight-i cut one the tablets in half and i put it inside of the water [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 female patient who received double salt denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unk, expiry date unknown) for dental cleaning.On (b)(6) 2018, the patient started polident overnight denture cleanser tablets at an unknown dose and frequency.On (b)(6) 2018, an unknown time after starting polident overnight denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and wrong technique in device usage process.Polident overnight denture cleanser tablets was discontinued on (b)(6) 2018 (dechallenge was unknown).On an unknown date, the outcome of the accidental device ingestion and wrong technique in device usage process were unknown.It was unknown if the reporter considered the accidental device ingestion and wrong technique in device usage process to be related to polident overnight denture cleanser tablets.Additional details, the adverse event information was received on (b)(6) 2018.The consumer reported that, "polident overnight-i cut one the tablets in half and i put it inside of the water and i drank a little bit of it in the morning without realizing what it was.Is it going to cause me any side effect? what should i do?".

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7175257
• MDR Text Key: 96752390
• Report Number: 1020379-2018-00002
• 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: 01/05/2018

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
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/09/2018
• 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