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

Lot Number 203059RGC

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

It gets down in my throat [accidental device ingestion].My mouth and my tongue is coated with red blotches on it.It is swollen [swollen tongue].My mouth and my tongue is coated with red blotches on it [red blotches].My mouth and my tongue is coated with red blotches on it.It is swollen [swollen mouth].I may be sensitive to some ingredients to this, what do i do other than call the doctor is i have an allergic reaction [hypersensitivity].I was on diflucan for 2 months before it cleared up for thrush [thrush].I don't use them everyday.I used them about 2-3 times a week [device used for unapproved schedule].I feel like i wash them good and soak them [wrong technique in device usage process].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in an (b)(6)-year-old female patient who received denture cleanser (polident 3 minute) tablet (batch number 203059rgc, expiry date 31st january 2023) for dental care.On (b)(6) 2020, the patient started polident 3 minute.On an unknown date, an unknown time after starting polident 3 minute, the patient experienced accidental device ingestion (serious criteria gsk medically significant), swollen tongue, red blotches, swollen mouth, hypersensitivity, thrush, device used for unapproved schedule and wrong technique in device usage process.The patient was treated with fluconazole (diflucan).Polident 3 minute was discontinued (dechallenge was positive).On an unknown date, the outcome of the accidental device ingestion, device used for unapproved schedule and wrong technique in device usage process were unknown and the outcome of the swollen tongue, red blotches, swollen mouth, hypersensitivity and thrush were recovering/resolving.It was unknown if the reporter considered the accidental device ingestion, thrush, device used for unapproved schedule and wrong technique in device usage process to be related to polident 3 minute.The reporter considered the swollen tongue, red blotches, swollen mouth and hypersensitivity to be related to polident 3 minute.Additional information.Adverse event information was received via call center representative on 30 june 2020.Consumer reported that, "i calling about the polident denture cleaner.My mouth and my tongue is coated with red blotches on it.It is swollen.I may be sensitive to some ingredients to this.I feel like i wash them good and soak them, what do i do other than call the doctor is i have an allergic reaction? the three to five minutes 84 ct.I think i have used 1 pack of 6.I started using it on sunday.I could barely talk my tongue was so swollen.I do not use them every day.I used them about 2-3 times a week.I have used the brand and it did the same thing to me.It gets down in my throat.I called last friday and i could not get an appointment.I was on diflucan for 2 months before it cleared up for thrush.I wanted to know what you could take to counter act this.They are a little bit better today.It started getting better late yesterday.I could barely talk.Do i get some compensation for this? i am going to the doctors on the sixth to see if it has damaged my vocal cords.I will not buy this product anymore i have learned my lesson.Lot number 203059rgc and expiration date 31 january 2023." also co suspect drug consider as in this case is unspecified medication (for unknown brand).

• Brand Name: POLIDENT 3 MINUTE
• 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: 10315918
• MDR Text Key: 208192645
• Report Number: 1020379-2020-00036
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Lot Number: 203059RGC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• 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