MAUDE Adverse Event Report: GLAXOSMITHKLINE LLC POLIDENT DENTU CREME TOOTHPASTE; DENTURE CLEANSER

Lot Number 4L22BH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Upon review of this case/report, it was determined that the initial report that was sent contained the wrong manufacturer number (1020379-2015-00005).The correct manufacturer number is 1314819-2016-00004, and it is associated with (b)(4) polident dentu creme toothpaste.

Event Description

Blisters in throat [oropharyngeal blistering].Blisters in mouth [blistering of mouth].Blisters on tongue [tongue blistering].Throat pain [throat pain].Sores in mouth [sores mouth].Device misuse [device misuse].Case description: this case was reported by a consumer and described the occurrence of blisters in throat in a (b)(6) female patient who received double salt denture cleanser (polident dentu creme toothpaste) toothpaste (batch number (b)(4), expiry date 30th september 2017) for denture wearer.On an unknown date, the patient started polident dentu creme toothpaste.On an unknown date, an unknown time after starting polident dentu creme toothpaste, the patient experienced blisters in throat (serious criteria gsk medically significant), blisters in mouth, blisters on tongue, throat pain and device misuse.The patient was treated with sodium chloride (salt water) and water.Polident dentu creme toothpaste was discontinued (dechallenge was positive).On an unknown date, the outcome of the blisters in throat, blisters in mouth, blisters on tongue and throat pain were unchanged and the outcome of the device misuse was recovered/resolved.It was unknown if the reporter considered the blisters in throat, blisters in mouth, blisters on tongue and throat pain to be related to polident dentu creme toothpaste.Additional details: the patient used polident dentu creme toothpaste for denture adhesion which represents device misuse.The patient discontinued use of polident dentu creme toothpaste.The consumer reported that she rinsed her mouth with salt water and it made her condition worse so she switched to plain water and rinsed her mouth all day with it.Follow-up information was received on 11 february 2015.The patient returned an incomplete authorization to contact physician form along with a note.She stated that she mistakenly used the cleanser for an adhesive, and it was in her mouth all night.She stated that she woke up with sores in her mouth and a sore throat.She reported that she called poison control and they suggested that she see her doctor, but she couldn't afford to do that.She stated that she rinsed her mouth several times a day for a week, and she "healed up fine".

• Brand Name: POLIDENT DENTU CREME TOOTHPASTE
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE LLC; 3169 route 145; east durham NY 12423
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 5806442
• MDR Text Key: 49954602
• Report Number: 1314819-2016-00004
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/10/2014

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: 09/30/2017
• Device Lot Number: 4L22BH
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 07/19/2016
• 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: 73 YR