MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP SA2; DENTURE ADHESIVE

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

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

Pneumothorax [pneumothorax].Altered state of consciousness [consciousness disturbed].Case description: this case was reported by a consumer via call center representative and described the occurrence of pneumothorax in a (b)(6) male patient who received double salt dental adhesive cream (new poligrip sa2) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sa2.On an unknown date, an unknown time after starting new poligrip sa2, the patient experienced pneumothorax (serious criteria gsk medically significant) and consciousness disturbed (serious criteria gsk medically significant).The action taken with new poligrip sa2 was unknown.On an unknown date, the outcome of the pneumothorax and consciousness disturbed were unknown.It was unknown if the reporter considered the pneumothorax and consciousness disturbed to be related to new poligrip sa2.[clinical course]: on an unknown date, when the patient used new poligrip sa2 (70g), he had a pneumothorax-like symptom and was about to lose consciousness.No further information is expected.

Manufacturer Narrative

(b)(4).

• Brand Name: NEW POLIGRIP SA2
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 13079225
• MDR Text Key: 287009255
• Report Number: 3003721894-2021-00408
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/23/2021
• 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: 66 YR
• Patient Sex: Male