MAUDE Adverse Event Report: POLIDENT; DENTURE CLEANSER

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

She thought it was for acid reflux and she took the tablet and drank it with water.[accidental device ingestion].She thought it was for acid reflux and she took the tablet and drank it with water.[device use in unapproved indication].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) tablet (batch number unk, expiry date unknown) for esophageal acid reflux.On an unknown date, the patient started polident at an unknown dose and frequency.On an unknown date, an unknown time after starting polident, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and device use in unapproved indication.The action taken with polident was unknown.On an unknown date, the outcome of the accidental device ingestion and device use in unapproved indication were unknown.It was unknown if the reporter considered the accidental device ingestion and device use in unapproved indication to be related to polident.Adverse event information was received via call on 19 september 2019.Consumer called in about polident and reported that, "my mother has acid reflux.She thought it was for acid reflux and she took the tablet and drank it with water.Do i need to take her to the hospital or what do i need to do? i don't have time to wait for you.Do i need to call my attorney? i need to speak to your supervisor".

• Brand Name: POLIDENT
• Type of Device: DENTURE CLEANSER
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9145119
• MDR Text Key: 167392043
• Report Number: 1020379-2019-00048
• 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: 09/19/2019

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: 09/19/2019
• Initial Date FDA Received: 10/02/2019
• 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: 87 YR