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

Lot Number UW9F

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I have tias / as soon as i stopped using it i stopped having tias they are mini-strokes [transient ischemic attack].I must have developed an allergy [device allergy].I had trouble getting my words together [speech disorder].Not to touch your eyes or mouth on the box now.I didn't know that / i used 2 instead of one, 2 tablets a night one for the upper and one for the lower [wrong technique in device usage process].Case description: this case was reported by a consumer via call center representative and described the occurrence of transient ischemic attack in a (b)(6)-year-old female patient who received denture cleanser (polident overnight denture cleanser tablets) tablet (batch number uw9f, expiry date 23rd february 2022) for dental cleaning.Co-suspect products included denture cleanser (polident overnight denture cleanser tablets) tablet for dental cleaning.On an unknown date, the patient started polident overnight denture cleanser tablets at an unknown dose and frequency and polident overnight denture cleanser tablets at an unknown dose and frequency.On an unknown date, an unknown time after starting polident overnight denture cleanser tablets and polident overnight denture cleanser tablets, the patient experienced transient ischemic attack (serious criteria gsk medically significant), device allergy, speech disorder and wrong technique in device usage process.Polident overnight denture cleanser tablets was discontinued in (b)(6) 2020 (dechallenge was positive).Polident overnight denture cleanser tablets was discontinued (dechallenge was positive).On an unknown date, the outcome of the transient ischemic attack was recovered/resolved and the outcome of the device allergy, speech disorder and wrong technique in device usage process were unknown.It was unknown if the reporter considered the transient ischemic attack, speech disorder and wrong technique in device usage process to be related to polident overnight denture cleanser tablets and polident overnight denture cleanser tablets.The reporter considered the device allergy to be related to polident overnight denture cleanser tablets and polident overnight denture cleanser tablets.Additional details: adverse event information received via call center representative on 26 august 2020.The consumer reported, "polident the whitening one.I have transient ischemic attack (tias) they all have persulfate in them i heard that the food drug and administration said to take it out.I was wondering if they plan to take them out.As soon as i stopped using it, i stopped having tias.They are mini-strokes.I've been using this for 60 years.I didn't know it was in there, and other people have complained about this too.They have had problems with the persulfates.It's a combination of chemicals, its in all the dental products except a small few.My daughter is the one who told me to look into the polident, and i was so surprised that it has so many chemicals in it.It says it's a deadly poison, it cause death, i must have developed an allergy, i looked it up and sure enough.It is a deadly poison.I never even opened it.I used 2 instead of one, 2 tablets a night one for the upper and one for the lower, thinking it would get them cleaner.I stopped using it about 5-6 weeks ago.I have a full box, even with minimal use you can have seizures and strokes.I was just at my doctor a few days ago, they said there was nothing there, even in the magnetic resonance imaging i know they took the zinc out of the stuff that holds the teeth in.I started having the tias a few years ago.I had trouble getting my words together, no paralysis.I don't have diabetes, high blood pressure, i'm in pretty good health.The doctor in the hospital couldn't figure out what was wrong.Yes, i have not had one since.It never said that in the beginning, not to touch your eyes or mouth on the box now.I didn't know that.Here i was using it for 60 years and never knew.I do not want a refund.I just want them to take it out.Please beg them for me, i want to use polident again".

• Brand Name: POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS
• 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: 10574199
• MDR Text Key: 208171398
• Report Number: 1020379-2020-00044
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2022
• Device Lot Number: UW9F
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• 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: 60 YR