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

Lot Number 4A12002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Respiratory Distress (2045); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident dentu gel.

Event Description

She was now disabled.She could not walk the halls.She was on oxygen.Case description: this case was reported by a consumer and described the occurrence of disability in a (b)(6) female patient who received double salt denture cleanser (polident dentu gel) gel (batch number (b)(4), expiry date unknown) for dental cleaning.The patient's past medical history included smoker and emphysema.On an unknown date, the patient started polident dentu gel.On an unknown date, an unknown time after starting polident dentu gel, the patient experienced disability (serious criteria disability, gsk medically significant and other: gsk medically significant), unable to walk (serious criteria gsk medically significant and other: gsk medically significant) and oxygen supplementation (serious criteria gsk medically significant and other: gsk medically significant).On an unknown date, the outcome of the disability was not recovered/not resolved and the outcome of the unable to walk and oxygen supplementation were unknown.It was unknown if the reporter considered the disability, unable to walk and oxygen supplementation to be related to polident dentu gel.Additional details, the adverse event information was reported on 13 december 2016.The consumer reported using polident dentu gel toothpaste for years.She did not have a clear start date.The consumer last used the product on (b)(6) 2016.The consumer was (b)(6).She stated she was now disabled.She stated this product had nothing to do with her condition since she had a history of emphysema and had been smoking for 50 years.The consumer stated that she became disabled within the last ten years.She did not give a clear start date of the disability.She stated she could not walk the halls and that she was on oxygen.The consumer would not speak with her doctor.The consumer also stated her product did not had a expiry date.The lot the consumer provided was 4a12002.

• Brand Name: POLIDENT DENTU GEL
• 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: 6177310
• MDR Text Key: 62542655
• Report Number: 1314819-2016-00008
• 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: 12/13/2016

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 Lot Number: 4A12002
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/15/2016
• 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; Disability
• Patient Age: 79 YR