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U.S. Department of Health and Human Services

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

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BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER 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 Type  Injury  
Event Description
My wife is recuperating and she swallowed the polident cleanser which was put on the table thinking it was a medicine.[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 female patient who received denture cleanser (polident denture cleanser) unknown for drug use for unknown indication.On an unknown date, the patient started polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced accidental device ingestion (serious criteria haleon medically significant).The action taken with polident 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 denture cleanser.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was received from consumer via call center representative (phone) on 15sep2023 and consumer reported that"my wife is recuperating and she swallowed the polident cleanser which was put on the table thinking it was medicine.Is it okay to swallow polident cleanser".
 
Manufacturer Narrative
Argus case: (b)(4).
 
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Brand Name
POLIDENT 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
8888255249
MDR Report Key17867748
MDR Text Key324878791
Report Number1020379-2023-00033
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 09/15/2023
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 09/15/2023
Initial Date FDA Received10/04/2023
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;
Patient SexFemale
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