MAUDE Adverse Event Report: GLAXOSMITHKLINE NEW POLIGRIP SG; DENTURE ADHESIVE

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Manufacturer Narrative

3003721894-2019-00070 is associated with argus case (b)(4).New poligrip sg is marketed in the us as super poligrip.

Event Description

Arrhythmia, expired device used.This case was reported by a consumer via call center representative and described the occurrence of arrhythmia in a (b)(6)-year-old male patient who received double salt dental adhesive cream (new poligrip sg) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sg.In (b)(6) 2019, an unknown time after starting new poligrip sg, the patient experienced expired device used and arrhythmia (serious criteria gsk medically significant).On an unknown date, the outcome of the arrhythmia and expired device used were unknown.It was unknown if the reporter considered the arrhythmia and expired device used to be related to new poligrip sg.Additional details: two or three days before this report, the patient used new poligrip sg 75 g which was bought 3 years before and had been used.Just around the initiation of the product, the patient had a feeling of arrhythmia.No further information is expected.

• Brand Name: NEW POLIGRIP SG
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE; dungarvan ltd; dungarvan; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park,; nc, NC 22709 ; 8888255249
• MDR Report Key: 8455463
• MDR Text Key: 139981212
• Report Number: 3003721894-2019-00070
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2019

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: 03/06/2019
• Initial Date FDA Received: 03/27/2019
• 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: 83 YR