MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIGRIP POWDER FA; DENTURE ADHESIVE

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

Patient Problems Dysphagia/ Odynophagia (1815); Pneumonia (2011); Choking (2464)

Event Type  Injury  

Manufacturer Narrative

The report # 3003721894-2019-00077 is associated with (b)(4).

Event Description

Choking [choking]; dysphagia [swallowing difficult]; contraindicated device used [contraindicated device used].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) year-old male patient who received denture adhesive powder-double salt (poligrip powder fa) oral powder for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started poligrip powder fa.On an unknown date, an unknown time after starting poligrip powder fa, the patient experienced choking (serious criteria gsk medically significant) and swallowing difficult.On an unknown date, an unknown time after starting poligrip powder fa, the patient experienced contraindicated device used.In 2018, an unknown time after starting poligrip powder fa, the patient experienced pneumonia aspiration (serious criteria gsk medically significant).On an unknown date, the outcome of the choking, pneumonia aspiration, swallowing difficult and contraindicated device used were unknown.It was unknown if the reporter considered the choking, swallowing difficult and contraindicated device used to be related to poligrip powder fa.The reporter considered the pneumonia aspiration to be unrelated to poligrip powder fa.Additional details: the patient had been using poligrip powder fb for decades.The patient had experienced pneumonia aspiration in the summer of 2018.It was unrelated to poligrip but caused by another factor.The patient had difficulty in swallowing food such as seared beef.Liquid was better, but it choked him.No further information is expected.

• Brand Name: POLIGRIP POWDER FA
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, co. waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 8469245
• MDR Text Key: 140590350
• Report Number: 3003721894-2019-00077
• Device Sequence Number: 1
• Product Code: KOT
• 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,foreign
• Type of Report: Initial
• Report Date: 03/07/2019

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: No Information
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/01/2019
• 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: 80 YR