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U.S. Department of Health and Human Services

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

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BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER TABLETS Back to Search Results
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 02/02/2023
Event Type  Injury  
Manufacturer Narrative
Argus case id: (b)(4).
 
Event Description
A customer accidentally drank the foaming tablet [accidental device ingestion].Case description: this case was reported by a other health professional via call center representative and described the occurrence of accidental device ingestion in a patient who received denture cleanser (polident denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On (b)(6) 2023, the patient started polident denture cleanser tablets.On (b)(6) 2023, an unknown time after starting polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).Polident denture cleanser tablets was discontinued on (b)(6) 2023 (dechallenge 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 denture cleanser tablets.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 received from an other health professional via call center representative (phone) on 02feb2023.The other health professional reported that, "this is a pharmacy here, i would like to ask what are the ingredients in polident denture cleansing tablets? a customer accidentally drank the foaming tablet, drank one, only added a little water, about one or two mouthfuls, the customer only brought a polident cleansing tablet here.It is an ordinary cleansing tablet product, the packaging is all green, so i don't know how many tablets there are, and i don't know the product information.Drank it today, and the customer didn't feel discomfort, but i have already asked him/her to go to the hospital.1) does the consumer agree to provide pii: no 2) does the consumer agree to follow-up? no 3) patient-caller relationship: pharmacy and consumer".
 
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Brand Name
POLIDENT 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 Key16434670
MDR Text Key310132698
Report Number1020379-2023-00007
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2023
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2023
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 Number1
Patient Outcome(s) Other;
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