MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DAILY CARE TABLETS; DENTURE CLEANSER

Lot Number 23CO73RG

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

Patient Problem Choking (2464)

Event Type  Injury  

Event Description

I used it twice, and i start to choke at night [choking].There must be something in there that i'm allergic to [device allergy].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a patient who received denture cleanser (polident daily care tablets) tablet (batch number 23co73rg, expiry date 28th february 2026) for product used for unknown indication.On an unknown date, the patient started polident daily care tablets.On an unknown date, an unknown time after starting polident daily care tablets, the patient experienced choking (serious criteria haleon medically significant) and device allergy.The action taken with polident daily care tablets was unknown.On an unknown date, the outcome of the choking and device allergy were unknown.It was unknown if the reporter considered the choking to be related to polident daily care tablets.The reporter considered the device allergy to be related to polident daily care tablets.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer via call center representative(phone) on (b)(6) 2023.It was reported that; "i wear a mouth guard, and for years i have always bought polident, and i buy the 3-minute one.By mistake, i saw polident and i took the one that's like daily care, and i used it once, i used it twice, and i start to choke at night, it's something terrible.There must be something in there that i'm allergic to.Could you just send me a refund, please? or send me a coupon and i'll throw this out and buy the other one.I have it right in front of me, sweetheart.Yes, i had to take the mouth guard out last night, i was choking.Don't apologize, i have the lot number, the expiry date, and the bar code right here.Okay, lot 23co73rg, exp 28feb2026.This one has 96 tablets.The one i always bought was the 3-minute one, and i never had a reaction.I saw polident, i figure out they're all the same, unfortunately, they're not.Do you also need the barcode? can i go sit now, or i have to continue? okay, now i can go sit down.Thank you.Out of curiosity.Can i ask you how much the gift card is for? sweetheart, i never kept the bill because i never had a problem with polident.I bought it at uh, i think i paid either seven or eight dollars plus tax in canada.I thank you.That's very nice of you.And i'm glad you support the products that you make.That's why it pays to buy something with a name.Can i ask you? how long does that take? because i run out and i got to go buy another box.Oh, i'm sorry.You told me email, okay.It's.The only problem is i'm having trouble with my printer, but i hope it's going to work.I don't have a smartphone.I'm an old lady.I don't use other things.Thank you, sweetheart.You said you want to do a survey? can we do it fast because i have a doctor's appointment coming up.".

Manufacturer Narrative

Argus case: (b)(4).

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a patient who received denture cleanser (polident daily care tablets) tablet (batch number 23co73rg, expiry date 28th february 2026) for product used for unknown indication.On an unknown date, the patient started polident daily care tablets.On an unknown date, an unknown time after starting polident daily care tablets, the patient experienced choking (serious criteria haleon medically significant) and device allergy.The action taken with polident daily care tablets was unknown.On an unknown date, the outcome of the choking and device allergy were unknown.It was unknown if the reporter considered the choking to be related to polident daily care tablets.The reporter considered the device allergy to be related to polident daily care tablets.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer via call center representative(phone) on 06sep2023.It was reported that; "i wear a mouth guard, and for years i have always bought polident, and i buy the 3-minute one.By mistake, i saw polident and i took the one that's like daily care, and i used it once, i used it twice, and i start to choke at night, it's something terrible.There must be something in there that i'm allergic to.Could you just send me a refund, please? or send me a coupon and i'll throw this out and buy the other one.I have it right in front of me, sweetheart.Yes, i had to take the mouth guard out last night, i was choking.Don't apologize, i have the lot number, the expiry date, and the bar code right here.Okay, lot 23co73rg, exp 28feb2026.This one has 96 tablets.The one i always bought was the 3-minute one, and i never had a reaction.I saw polident, i figure out they're all the same, unfortunately, they're not.Do you also need the barcode? can i go sit now, or i have to continue? okay, now i can go sit down.Thank you.Out of curiosity.Can i ask you how much the gift card is for? sweetheart, i never kept the bill because i never had a problem with polident.I bought it at uh, i think i paid either seven or dollar8 plus tax in canada.I thank you.That's very nice of you.And i'm glad you support the products that you make.That's why it pays to buy something with a name.Can i ask you? how long does that take? because i run out and i got to go buy another box.Oh, i'm sorry.You told me email, okay.It's.The only problem is i'm having trouble with my printer, but i hope it's going to work.I don't have a smartphone.I'm an old lady.I don't use other things.Thank you, sweetheart.You said you want to do a survey? can we do it fast because i have a doctor's appointment coming up." follow up was received via email on 13sep2023.It was reported that "we can confirm that the consumer experienced choking and a drug allergy due to using the product.Indeed the consumer can be considered as elderly.The consumer did not provide their age".As per follow up causality of event choking was updated to yes.Patient age group was updated as elderly.

• Brand Name: POLIDENT DAILY CARE 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: 17772104
• MDR Text Key: 323689887
• Report Number: 1020379-2023-00032
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/06/2023

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
• Device Lot Number: 23CO73RG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 10/11/2023
• 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