MAUDE Adverse Event Report: BLOCK DRUG CO., INC POLIDENT (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Accidentally swallow it [accidental device ingestion].Case description: this case was reported by a consumer via interactive digital media (facebook) and described the occurrence of accidental device ingestion in a patient who received polident (polident (unspecified denture adhesive or denture cleanser)) unknown (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started polident (unspecified denture adhesive or denture cleanser).On an unknown date, an unknown time after starting polident (unspecified denture adhesive or denture cleanser), the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: haleon medically significant) and product complaint.The action taken with polident (unspecified denture adhesive or denture cleanser) was unknown.On an unknown date, the outcome of the accidental device ingestion and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident (unspecified denture adhesive or 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 from consumer on (b)(6) 2022 via interactive digital media (facebook).The consumer reported that " when you use, polident, when you drink cold water or coffee, it comes off, and then you accidentally swallow it.Polident if you drink cold water or coffee, the stickiness will disappear, it keeps getting swallowed up." qa result was received on (b)(6) 2022 from quality assurance (qa) department regarding 04230072 (issue number) for unknown lot number and expiry date.Pqc evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.Response to consumer: no sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information is not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a 'batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed and approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.The investigation reports concluded that complaint stands inconclusive.Pqc number was reported as (b)(4).Follow up was received on 22nov2022.As per follow there was no new information updated to the case.

• Brand Name: POLIDENT (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): BLOCK DRUG CO., INC; memphis TN
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 15930699
• MDR Text Key: 304957917
• Report Number: 1020379-2022-00034
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 11/13/2022

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?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2022
• Initial Date FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 1) NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other