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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Consumer reported someone swallowed water with polident effervescent tablet [accidental device ingestion].Case description: this case was reported by a non-health professional via call center representative and described the occurrence of accidental device ingestion in a patient who received denture cleanser (polident) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident.On an unknown date, an unknown time after starting polident, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with polident 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.Additional details: the adverse event was reported by a non-health professional via call center representative (phone) on 19oct2021.The consumer stated that " i received a report from a store that a consumer had reported someone swallowing water with polident effervescent tablet.I do not have any details for the said consumer.".

• Brand Name: POLIDENT
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 12750823
• MDR Text Key: 280084810
• Report Number: 1020379-2021-00060
• 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: foreign
• Type of Report: Initial
• Report Date: 10/19/2021

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 Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 11/04/2021
• 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