MAUDE Adverse Event Report: POLIDENT DENTURE CLEANSER TABLETS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(6).

Event Description

Took one tablet of polident denture cleanser [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident denture cleanser tablets) tablet for product used for unknown indication.Concurrent medical conditions included dementia.On an unknown date, the patient started polident denture cleanser tablets at an unknown dose and frequency.On (b)(6) 2020, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with polident denture cleanser tablets was unknown.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 denture cleanser tablets.Additional details: consumer said a family member with dementia gave one tablet of polident denture cleanser tables to another family member to take.Agent asked consumer to bring family member for consultation immediately and asked the situation of consumer's family member.Consumer said family member just took it.Agent asked consumer to bring family member for consultation immediately.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 10346976
• MDR Text Key: 201558451
• Report Number: 1020379-2020-00037
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2020
• 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