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

Device Problem Insufficient Information (3190)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4).Polident denture cleanser is marketed as polident tablet in the us.

Event Description

Gastritis erosive [gastric erosions].Gastric disorder [gastric disorder].This case was reported by a consumer via call center representative and described the occurrence of gastric erosions in a male patient who received double salt denture cleanser (polident denture cleanser (unknown)) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started polident denture cleanser (unknown).In (b)(6) 2016, unknown after starting polident denture cleanser (unknown), the patient experienced gastric erosions (serious criteria gsk medically significant) and gastric disorder.The patient was treated with medication unknown (unknown drug).On an unknown date, the outcome of the gastric erosions was not recovered/not resolved and the outcome of the gastric disorder was unknown.It was not reported if the reporter considered the gastric erosions and gastric disorder to be related to polident denture cleanser (unknown).January 2016: the patient underwent gastroscopy for an upset stomach (gastric disorder).He was then told that there were erosions in his stomach and started taking a prescribed drug.He usually washed his dentures with polident denture cleanser (unknown) twice a week, but rinsing after the wash might occasionally have been insufficient.

• Brand Name: POLIDENT DENTURE CLEANSER (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5456715
• MDR Text Key: 38888128
• Report Number: 1020379-2016-00002
• 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: 01/29/2016

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: No Information
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/24/2016
• 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