MAUDE Adverse Event Report: BLOCK DRUG CO., INC JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC51038; DENTURE CLEANSER

Lot Number W96U

Device Problem Product Quality Problem (1506)

Patient Problem Cancer (3262)

Event Type  Injury  

Event Description

Neoplasm malignant [carcinoma].Case description: this case was reported by a consumer via call center representative and described the occurrence of carcinoma in a 74-year-old male patient who received denture cleanser (japanese polident for partials (with sodium percarbonate)-mfc51038) tablet (batch number n96m, expiry date unknown) for denture wearer.Concurrent medical conditions included denture wearer and living in residential institution.On an unknown date, the patient started japanese polident for partials(with sodium percarbonate)-mfc51038.On an unknown date, an unknown time after starting japanese polident for partials(with sodium percarbonate)-mfc51038, the patient experienced carcinoma (serious criteria gsk medically significant), wrong technique in product usage process and product quality issue.The action taken with japanese polident for partials(with sodium percarbonate)-mfc51038 was unknown.On an unknown date, the outcome of the carcinoma, wrong technique in product usage process and product quality issue were unknown.It was unknown if the reporter considered the carcinoma to be related to japanese polident for partials(with sodium percarbonate)-mfc51038.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on (b)(6) 2022, the patient bought japanese polident for partials (108 tablets) at the store a.On an unknown date, as the product containing 108 tablets was too large to place on the sink, the patient cut sheets in advance and put those into an empty box of japanese polident for partials (48 tablets) to use.However, even though he just bought the product, many products appeared powdery.As of the reporting date, he had cancer and was living in a residential institution instead of his home.No further information is expected.Follow-up information received from the reporting consumer on 30-sep-2022 [clinical course] on 30th september 2022, lot # was changed from n96m to w96u.

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC51038
• 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 Key: 15624364
• MDR Text Key: 301925150
• Report Number: 1020379-2022-00026
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/26/2022

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
• Device Lot Number: W96U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/18/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male