MAUDE Adverse Event Report: POLIDENT ANTI BACTERIAL; DENTURE CLEANSER

Lot Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Veeva case: (b)(4).
Event or Problem Description
A patient swallowed a lozenge [accidental device ingestion] case description: on 2024-10-04, a spontaneous case was reported in france by a(n) other health professional via call centre representative (phone).The report concerns a consumer.The consumer received polident anti-bacterial (napc+potm+taed tablet) for product use for unknown indication.No concomitant medications were reported.On an unknown date, after an unknown time of starting polident anti-bacterial, the consumer experienced a medically significant a patient swallowed a lozenge (preferred term: accidental device ingestion).The outcome of the event was unknown.No medical history was reported.No drug history was reported.The action taken for polident anti-bacterial was unknown.Dechallenge was unknown.Rechallenge was no/n/a.Reporter causality for the event with the suspect was reported as not reported/not assessable.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.The reporter provided the following comment: " this is the poison control center at the (b)(6) hospital in (b)(6).I am calling you; we had a case of exposure with a polident product and i would need to have the email address of someone from the quality department or the regulatory department in order to obtain the composition of this product.A patient swallowed a lozenge.Polident antibacterial 72 lozenges.The product is at the patient's home.I cannot give you the batch and expiration date.I will receive the thematic symptoms and the label/packaging on both sides." the report is being resubmitted to capture corrections.The information was received on 2024-10-24 and is as follows: device report type added as serious injury.

• Brand Name: POLIDENT ANTI BACTERIAL
• Common Device Name: DENTURE CLEANSER
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 20564470
• Report Number: 1314819-2024-00098
• Device Sequence Number: 8034861
• Product Code: EFT
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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
• Operator of Device: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown