MAUDE Adverse Event Report: GSK EAST DURHAM POLIDENT DENTU CREME; DENTURE CLEANSER

Lot Number ILIT258H

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Reaction (2414); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

I might have swallowed some [accidental device ingestion], cause breathing issues and all this is that true [difficulty breathing], i brushed my teeth with this [device use issue], this case was reported by a consumer and described the occurrence of accidental device ingestion in a (b)(6) female patient who received denture cleanser (polident dentu creme) toothpaste (batch number ilit258h, expiry date 31st march 2020) for dental cleaning.On an unknown date, the patient started polident dentu creme.On an unknown date, an unknown time after starting polident dentu creme, the patient experienced accidental device ingestion (serious criteria gsk medically significant), difficulty breathing and device use issue.The action taken with polident dentu creme was unknown.On an unknown date, the outcome of the accidental device ingestion, difficulty breathing 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 dentu creme.The reporter considered the difficulty breathing to be related to polident dentu creme.Additional details: the adverse event information was received via phone call on (b)(6) 2019.The consumer reported that, "i am calling in about polident creme, i brushed my teeth with this, i did not mean too.I looked it up online, it could cause breathing issues and all this, is that true? i might have swallowed some.".

• Brand Name: POLIDENT DENTU CREME
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GSK EAST DURHAM; east durham; NY
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 8469168
• MDR Text Key: 140453742
• Report Number: 1314819-2019-00002
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Lot Number: ILIT258H
• Date Manufacturer Received: 03/18/2019
• 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): Other
• Patient Age: 58 YR