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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The 1020379-2018-00053 is associated with argus case (b)(6) polident (unspecified denture adhesive or denture cleanser).Polident denture adhesive is marketed as super poligrip in the us.The suspect product in this report will be submitted as a denture cleanser until the suspect product can be confirmed.

Event Description

Heart pain [cardiac pain].Liver pain [hepatic pain].Suspected accidental product ingestion [accidental device ingestion].Case description: this case was reported by a consumer via interactive digital media and described the occurrence of cardiac pain in a patient who received polident (polident (unspecified denture adhesive or denture cleanser)) unknown for product used for unknown indication.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 cardiac pain (serious criteria gsk medically significant), hepatic pain and accidental device ingestion (serious criteria gsk medically significant).On an unknown date, the outcome of the cardiac pain and hepatic pain were not reported and the outcome of the accidental device ingestion was unknown.It was unknown if the reporter considered the cardiac pain, hepatic pain and accidental device ingestion to be related to polident (unspecified denture adhesive or denture cleanser).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the report was received from patient via social media ((b)(6)) on (b)(6) 2018.The patient experienced heart and liver pain after suspected accidental polident product ingestion.Although trade name selected in argus was polident (unspecified denture adhesive or denture cleanser), the suspect product was not sure about which one of polident in fact.Action taken with polident was unknown.

• Brand Name: POLIDENT (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 7843212
• MDR Text Key: 119152660
• Report Number: 1020379-2018-00053
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 08/23/2018
• 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