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

Lot Number 18C069RGC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Irritation (1941); Discomfort (2330); Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The report # 3005372036-2018-00003 is associated with (b)(4), polident 3 minute 84 count (pharmatech).

Event Description

Was just wondering if ingesting any of the residue would cause any problems.[accidental device ingestion].Residue would leave my mouth very dry [dry mouth].It is irritating my mouth [mouth irritation].Making my mouth uncomfortable.[oral discomfort].Noticed the residue of the polident would get into the dentures [medication residue present].Guess this must be a new product of the polident because i usually get the overnight/ have been using this product overnight, i didn't know you could only use this for 3 minutes [device use issue].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6)-year-old female patient who received denture cleanser (polident 3 minute) tablet (batch number 18c069rgc, expiry date 28th february 2021) for dental cleaning.On an unknown date, the patient started polident 3 minute.On (b)(6) 2018, an unknown time after starting polident 3 minute, the patient experienced dry mouth, mouth irritation, oral discomfort and device use issue.On an unknown date, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and medication residue present.The action taken with polident 3 minute was unknown.On an unknown date, the outcome of the accidental device ingestion, dry mouth, mouth irritation, oral discomfort, medication residue present and device use issue were unknown.It was unknown if the reporter considered the accidental device ingestion and device use issue to be related to polident 3 minute.The reporter considered the dry mouth, mouth irritation, oral discomfort and medication residue present to be related to polident 3 minute.Additional details, adverse event information was received on 22 august 2018.Consumer reported that "i guess this must be a new product of the polident because i usually get the overnight.I noticed the residue of the polident would get into the dentures and now i can't use them.I was just wondering if ingesting any of the residue would cause any problems.The residue would leave my mouth very dry.I want to know how to get the residue out of my dentures.It is irritating my mouth.I just got my dentures.Making my mouth uncomfortable".This report is being resubmitted to capture corrections for initial version dated on (b)(6) 2018.The suspect product was updated to polident 3 minute 84 count (pharmatech) from polident 3 minute.The start date of suspect was captured as (b)(6) 2018.On (b)(6) 2018, less than a day after starting polident 3 minute, the patient experienced dry mouth, mouth irritation, oral discomfort.The verbatim was updated as "i guess this must be a new product of the polident because i usually get the overnight.I have been using this product overnight, i didn't know you could only use this for 3 minutes".No more corrections were made.

• 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 ; 8888255249
• MDR Report Key: 7834423
• MDR Text Key: 118871943
• Report Number: 3005372036-2018-00003
• 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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Lot Number: 18C069RGC
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 08/30/2018
• 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: 81 YR