MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT TOTAL ACTION TABLET (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 Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

Argus case number: (b)(4).

Event Description

My father swallowed two tablets/we are not sure that they have been swallowed it [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 94-year-old male patient who received denture cleanser (polident total action tablet (denture cleanser)) tablet for denture wearer.On an unknown date, the patient started polident total action tablet (denture cleanser) (oral) 2 dosage form(s) at an unknown frequency.On (b)(6) 2022, an unknown time after starting polident total action tablet (denture cleanser), the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with polident total action tablet (denture cleanser) 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 total action tablet (denture cleanser).This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received by consumer via call center representative (phone) on (b)(6) 2022.The consumer reported , "my father is 94 years old polydent and uses polident total action to clean the cleaner we found two paper foil today in the bathroom maybe my father swallowed two tablets.We have this concern, we are not sure of the adverse event - no, all normal for now, no adverse event we are not sure that they have been swallowed it has happened today and so far there's no adverse event spoke to the doctor- yes, the doctor told me to speak to you too".

• Brand Name: POLIDENT TOTAL ACTION TABLET (DENTURE CLEANSER)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 15758780
• MDR Text Key: 303308263
• Report Number: 1020379-2022-00028
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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: 10/13/2022
• 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: 94 YR
• Patient Sex: Male