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

Lot Number 104982XA

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems Rash (2033); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Mfr report is associated with argus case (b)(4), polident 3 minute.

Event Description

Rash on chest and arm [rash].I took the tablet out and put it in and clean her teeth [wrong technique in device usage process].Was reading the box to look for an expiration date on the product and the only date on here is 2015 [expired device used].Case description: this case was reported by a consumer and described the occurrence of rash in a (b)(6) female patient who received denture cleanser (polident 3 minute) tablet (batch number 104982xa, expiry date 2015) for dental cleaning.Concurrent medical conditions included diabetes and blood pressure high.On an unknown date, the patient started polident 3 minute at an unknown dose and frequency.On an unknown date, an unknown time after starting polident 3 minute, the patient experienced rash (serious criteria hospitalization), wrong technique in device usage process and expired device used.Polident 3 minute was continued with no change.On an unknown date, the outcome of the rash, wrong technique in device usage process and expired device used were unknown.It was unknown if the reporter considered the rash, wrong technique in device usage process and expired device used to be related to polident 3 minute.Additional information: adverse event information was received on 30 january 2019.The consumer stated."i am calling regarding polident, the tablet for cleaning teeth.I was reading the box to look for an expiration date on the product and the only date on here is 2015.I mean is there an expiry date for this?.My mother is been breaking out for a month and a half now.And i realized this is the box i found from her medicine cabinet to use for her teeth.And ones that we were using prior to this has no problems.He had this rash on chest and arm for a month and a half.She is diabetic and cannot have sodium because of her high blood pressure.I am reading the ingredient and a lot of them are sodium.She is still using the product.She had dentures since 1980.This batch for 84 tablets she had 20 left out of 84 tablets.I do this for her twice or three times a week.I cleanse this and use toothbrush.She is in the hospital 5 days ago for this rash.She wanted to go because she can't take it no more.The cream is not helping.She had antibiotics, cream calamine you name it we had it.This is the only drug she's been using.Cause we just started this box over a month ago.The hospital advise her to see an allergologist and she only have a dermatologist.They supposed to have a test on her blood.I would like to know if thee are any kind of reactions that people get after using it for so many years.I mean handle them.I took the tablet out and put it in and clean her teeth and i have it too so i am wondering if there is anything that is in there that causing the reaction.I had rashes on my chest and arm same with my mother." this case link to case # (b)(4).

• 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: 8318100
• MDR Text Key: 135522144
• Report Number: 1020379-2019-00006
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 104982XA
• Date Manufacturer Received: 01/30/2019
• 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): Hospitalization
• Patient Age: 84 YR