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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stomach Ulceration (4488)

Event Type  Injury  

Event Description

Even have gastric ulcer [gastric ulcer].Gas in stomach and has never stopped before [gas in stomach].Case description: this case was reported by a consumer via call center representative and described the occurrence of gastric ulcer in a 80-year-old male patient who received denture cleanser (polident for partials denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included hypertension.On an unknown date, the patient started polident for partials denture cleanser tablets.On an unknown date, an unknown timeafter starting polident for partials denture cleanser tablets, the patient experienced gastric ulcer (serious criteria gsk medically significant) and gas in stomach.The action taken with polident for partials denture cleanser tablets was unknown.On an unknown date, the outcome of the gastric ulcer and gas in stomach were unknown.It was unknown if the reporter considered the gastric ulcer and gas in stomach to be related to polident for partials denture cleanser tablets.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 received from consumer via call center representative (phone) on 10nov2022.The consumer stated that "i bought cleansing tablets for the elderly at home to use.The denture of the elderly at home is a partial one and has gold portion.But i bought it wrongly.Bought cleansing tablets for full mouth/half mouth [type of dentures].Can partial dentures use polident full mouth/half mouth cleansing tablet? after using polident denture cleanser, will there be residual material on the dentures? because after the elderly at home used polident, felt repeatedly that there is gas in stomach and has never stopped before.Occasionally will even have gastric ulcer, hence more worried whether it is related to polident cleansing tablets.Usually, the elderly takes medication for hypertension.Approximately used polident cleansing tablets for 1-2 years' time already.".

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: POLIDENT FOR PARTIALS DENTURE CLEANSER TABLETS
• 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: 15922770
• MDR Text Key: 304872157
• Report Number: 1020379-2022-00033
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/10/2022

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/06/2022
• 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: 80 YR
• Patient Sex: Male