MAUDE Adverse Event Report: PHARMATECH AS PTI ROYSTON LLC POLIDENT 3 MINUTE 84 COUNT (PHARMATECH); DENTURE CLEANSER

Lot Number 18C071RGC

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

Mfr report # 3005372036-2018-00006 associated with argus case (b)(4), polident 3 minute (pharmatech).Product quality investigation on 13 september 2018 for complaint (b)(4), concluded a sample was returned and met all process and analytical testing specifications at the time of release.

Event Description

Chemical burn in mouth [chemical burn of oral cavity].He had blisters in his mouth [blistering of mouth].His mouth started to be on fire [burning mouth].Patient was stating he still has a bad taste in his mouth, like bleach [dysgeusia].Because his mouth hurt and he had no more medicine [oral pain].Case description: this case was reported by a consumer and described the occurrence of blistering of mouth in a (b)(6) male patient who received denture cleanser (polident 3 minute) tablet (batch number 18c071rgc, expiry date 28th february 2021) for dental cleaning.This case was associated with a product complaint.Concurrent medical conditions included diabetes.On (b)(6) 2018, the patient started polident 3 minute at an unknown dose and frequency.On (b)(6) 2018, 1 days after starting polident 3 minute, the patient experienced blistering of mouth.On (b)(6) 2018, the patient experienced burning mouth.On an unknown date, the patient experienced dysgeusia, device use error, product complaint and oral pain.Polident 3 minute was discontinued on (b)(6) 2018 (dechallenge was unknown).On an unknown date, the outcome of the blistering of mouth, dysgeusia, device use error, product complaint and oral pain were unknown and the outcome of the burning mouth was not recovered/not resolved.It was unknown if the reporter considered the blistering of mouth, burning mouth, dysgeusia and oral pain to be related to polident 3 minute.Additional information: adverse event information was received on (b)(6) 2018.Consumer reported that, "i was calling for my father.He started using a new box of polident 3 minute monday night.He realized the first tablets was not foaming, so he used another one that was not foaming too much either.He left his dentures in the product with water for about 6 minutes.Tuesday morning he put his dentures in and his mouth started to be on fire, then he had blisters in his mouth.He kept his dentures for the day and we had to go to the emergency room at 10:30 pm.He stayed until 4:30 am today." follow up information received on (b)(4) 2018.Product lot code was updated to lot 18c071rgc from 18c071rg.Follow up information was received on (b)(4) 2018 from the quality assurance (qa) department regarding issue (b)(4), lot code 18c071rgc.Quality report concluded that, product sample has not been returned, complaint was unconfirmed, product met all in process and analytical testing specification.Complaint might be closed as unsubstantiated.Follow up information was received on (b)(4) 2018.Patient was still suffering from (b)(6) 2018.He did not have any more medicine and had to go back to the hospital last night at 10:30 until 2:00 am.Patient was stating he still has a bad taste in his mouth, like bleach.This report is being resubmitted to capture corrections for initial version dated on (b)(6) 2018.For the suspect product polident 3 minute was updated as polident 3 minute 84 count (pharmatech).No more corrections were made.Follow up information was received on (b)(4) 2018.Product sample polident 3 minute, 84ct box received with lot code 18c071rgc (48 tablets returned) and expiry date february 2021.Follow-up information was received on (b)(4) 2018 from the quality assurance (qa) department regarding complaint number (b)(4) for lot number 18c071rgc.Quality investigation report included that a sample was received on 10 september 2018.The sample was received in a zip top bag, that contained a opened compromised (b)(4)-count carton, with the number lot 18c071rgc, expiration date february 2021, and 47 tablets.The tablets of sleeves were visually inspected and revealed that all tablets within each strip had a normal appearance.The foil was smooth and tablets were intact.The complaint was unconfirmed.Product met all in process and analytical testing specification at the time of release.Follow up information was received on 03 october 2018 via returned consumer authorization form.Consumer has provided physicians contact information.Consumer had provided lot number 18c71r6 and expiry date 29 february 2020 in auth form.However, on 4 september 2018 sample was received with lot number 18c071rgc and expiry date 29 february 2020.Hence lot number code was not updated.Follow up information was received on 8 november 2018.The event of chemical burn of the mouth was added in the case.It was unknown if the reporter considered the chemical burn of the mouth to be related to polident 3 minute.On an unknown date, the outcome of the chemical burn of the mouth was unknown.

• Brand Name: POLIDENT 3 MINUTE 84 COUNT (PHARMATECH)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): PHARMATECH AS PTI ROYSTON LLC; royston GA
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 8074952
• MDR Text Key: 127352224
• Report Number: 3005372036-2018-00006
• 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: 08/22/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Lot Number: 18C071RGC
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 78 YR