MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE DENTURE CLEANSER TABLETS

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  

Event Description

Some medicine and took it because of , but this is polident 3- minute denture, i didn't pay attention [accidental device ingestion] my head hurts [headache] spitting up blood [sputum bloody] i felt sick to my stomach [stomach discomfort] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received denture cleanser (polident 3 minute denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident 3 minute denture cleanser tablets.On an unknown date, an unknown time after starting polident 3 minute denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria haleon medically significant), headache, sputum bloody and stomach discomfort.The action taken with polident 3 minute denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion, headache, sputum bloody and stomach discomfort were unknown.It was unknown if the reporter considered the accidental device ingestion, headache, sputum bloody and stomach discomfort to be related to polident 3 minute denture cleanser tablets.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer via call center representative (phone) on 27nov2023.It was reported that "i have a little question, i bought some medicine and accidentally took it because of alka seltzer, but this is polident 3 minute denture cleanser, antibacterial, to clean teeth.I felt sick to my stomach, i didn't pay attention, i thought it was alka seltzer, i took 2, could it hurt me, poison me or something like that? it's like.It says here, if they take it, call police control doctor, i imagine it's poison.My head hurts after i take that and i'm spitting up blood.".

Manufacturer Narrative

Argus case: (b)(6).

• Brand Name: POLIDENT 3 MINUTE DENTURE CLEANSER TABLETS
• 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 ; 8888255249
• MDR Report Key: 18334281
• MDR Text Key: 330593936
• Report Number: 1020379-2023-00039
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2023

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: 11/27/2023
• Initial Date FDA Received: 12/15/2023
• 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 Sex: Male