MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED); DENTURE CLEANSER

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Inflammation (1932); Immunodeficiency (2156); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4) japanese polident for partials (polident for partials with taed).Japanese polident for partials is marketed as polident tablets in the us.

Event Description

Cholecystitis [cholecystitis], neoplasm malignant [carcinoma], decreased immune responsiveness [decreased immune, responsiveness].Case description: this case was reported by a consumer via call center representative and described the occurrence of carcinoma in a (b)(6) male patient who received denture cleanser (japanese polident for partials (polident for partials with taed)) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started japanese polident for partials (polident for partials with taed) (other) at an unknown dose and frequency.On an unknown date, an unknown time after starting japanese polident for partials (polident for partials with taed), the patient experienced wrong technique in product usage process.On an unknown date, an unknown time after starting japanese polident for partials (polident for partials with taed), the patient experienced decreased immune responsiveness.On an unknown date, an unknown time after starting japanese polident for partials (polident for partials with taed), the patient experienced cholecystitis (serious criteria gsk medically significant).On an unknown date, an unknown time after starting japanese polident for partials (polident for partials with taed), the patient experienced carcinoma (serious criteria gsk medically significant).The action taken with japanese polident for partials (polident for partials with taed) was unknown.On an unknown date, the outcome of the carcinoma, cholecystitis and decreased immune responsiveness were not recovered/not resolved and the outcome of the wrong technique in product usage process was unknown.It was unknown if the reporter considered the carcinoma, cholecystitis and decreased immune responsiveness to be related to japanese polident for partials (polident for partials with taed).Additional details the patient had been using japanese polident for partials (polident for partials with taed) for 20 years.On the morning of (b)(6) 2018, the patient's wife found for the first time that the patient had been using the product in an incorrect way.The patient poured in just enough water to cover the dentures without measuring the amount of water and soaked his toothbrush together in the product solution overnight.On the following morning, the patient brushed the teeth in the mouth using his toothbrush soaked in the polident solution without rinsing.The patient told his wife that he had brushed the dentures and the teeth in such a way for a long time.His wife told the patient to be careful not to use the product in such a way because it was not a toothpaste, but the patient would not listen to his wife.The patient did not read the product explanation at all in this manner.Recently, the patient had a weakened immune system and suffered from cholecystitis and cancer.His wife was scheduled to have the patient consult the primary care physician first.No further information is expected.

• Brand Name: JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park,, NC 27709 ; 8888255249
• MDR Report Key: 8038535
• MDR Text Key: 126235710
• Report Number: 1020379-2018-00067
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Date Manufacturer Received: 10/30/2018
• 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: 0
• Patient Outcome(s): Other
• Patient Age: 80 YR