MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE; DENTURE CLEANSER

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

Patient Problems Inflammation (1932); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Mfr report 1020379-2016-00005 is associated with (b)(4), polident 3 minute.

Event Description

Esophageal problem/fungus that goes all the way down to her esophagus [fungal esophagitis].Oral mycosis [oral fungal infection].Case description: this case was reported by a consumer and described the occurrence of oral fungal infection in a (b)(6)-year-old female patient who received double salt denture cleanser (polident smokers denture cleanser tablets) tablet (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident smokers denture cleanser tablets.On an unknown date, an unknown time after starting polident smokers denture cleanser tablets, the patient experienced oral fungal infection.Polident smokers denture cleanser tablets was discontinued (dechallenge was negative).On an unknown date, the outcome of the oral fungal infection was not recovered/not resolved.It was unknown if the reporter considered the oral fungal infection to be related to polident smokers denture cleanser tablets.Additional details, the consumer reported an adverse event of fungal infection for both him, (b)(4) and his mother while using the product.His mother had seen a doctor and was given medication which did not work.The consumer stated they will follow up with their doctor.The consumer had agreed to receive an hcp form via mail.The patient used unspecified medication as treatment drug.Adverse event revision information received on 04 april 2016.Adverse event information was received on 30 march 2016.The consumer did not report his mother experienced oral fungal infection following use of polident smokers.The consumer reported that both he and his mother have been using polident 3 minute and that she experienced oral mycosis and esophageal problem which he further described as the doctor looked at the roof of my mother's mouth and found fungus that went all the way down to her esophagus.The consumer reported his mother was being treated with an unknown prescribed medication and reported that it did not work.It was unknown if the reporter considered the fungal esophagitis and oral fungal infection to be related to polident smokers denture cleanser tablets.No further information was reported.

• Brand Name: POLIDENT 3 MINUTE
• 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: 5569557
• MDR Text Key: 42419626
• Report Number: 1020379-2016-00005
• 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
• Type of Report: Initial
• Report Date: 03/30/2016

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: Lay User/Patient
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/12/2016
• 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
• Patient Age: 82 YR