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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

The 1020379-2018-00045 is associated with argus case (b)(4), polident overnight denture cleanser tablets.

Event Description

She had something in her mouth which she said did not taste good the only thing we have in the bathroom is polident overnight whitening tablets.[accidental device ingestion].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number unk, expiry date unknown) for dental care.Concurrent medical conditions included dementia.On an unknown date, the patient started polident overnight denture cleanser tablets.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).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.Additional details, adverse event information was received on (b)(6) 2018.Consumer reported that "my mom has dementia and she went to the bathroom and had something in her mouth which she said did not taste good and the only thing we have in the bathroom is polident overnight whitening tablets.Can she die from just one tablet? what should i do if she ingested it?".

• Brand Name: POLIDENT OVERNIGHT 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
• MDR Report Key: 7782580
• MDR Text Key: 117134041
• Report Number: 1020379-2018-00045
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 08/07/2018
• 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