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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Pancreatitis (4481)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Pancreatitis chronic [chronic pancreatitis].Case description: this case was reported by a consumer via call center representative and described the occurrence of chronic pancreatitis in a 76-year-old male patient who received double salt dental adhesive cream (new poligrip) cream for denture wearer.Co-suspect products included 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 new poligrip and poligrip powder fa.On an unknown date, an unknown time after starting new poligrip and poligrip powder fa, the patient experienced chronic pancreatitis (serious criteria gsk medically significant), device use error and circumstance or information capable of leading to medication error.The action taken with new poligrip was unknown.The action taken with poligrip powder fa was unknown.On an unknown date, the outcome of the chronic pancreatitis was recovering/resolving and the outcome of the device use error and circumstance or information capable of leading to medication error were unknown.It was unknown if the reporter considered the chronic pancreatitis to be related to new poligrip.It was unknown if the reporter considered the device use error and circumstance or information capable of leading to medication error to be related to poligrip powder fa.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] on an unknown date, when new poligrip was used before, chronic pancreatitis (seriousness: gsk medically significant) was developed.The physician told the patient to use polygrip powder because new poligrip contained oils such as petroleum jelly and paraffin, so he switched to powder.On an unknown date, the use of poligrip powder fa was initiated.On an unknown date, the outcome of chronic pancreatitis was resolving.The test data also improved after the switch to powder preparation.On an unknown date, when the use of polygrip powder was initiated, his dentures fitted and so applying once a day was enough.Now, however, the denture did not fit.The dentist said that it was better to use powder three times a day than to force the dentures to fit, and if they did not fit then, to get another set of dentures made.Usually the new dentures were made every half year or a year.If poligrip powder was used three times a day, a 50 g bottle of poligrip powder could be used for about six months, which was not a lot of use.No further information is expected.

• Brand Name: NEW POLIGRIP
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 16276750
• MDR Text Key: 308529568
• Report Number: 3003721894-2023-00010
• 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: 01/11/2023

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: 01/11/2023
• Initial Date FDA Received: 02/01/2023
• 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: 76 YR
• Patient Sex: Male