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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Faecaloma [faecal impaction].Abdominal distension [bloating].Case description: this case was reported by a consumer via call center representative and described the occurrence of faecal impaction in a 80-year-old 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 faecal impaction (serious criteria gsk medically significant) and bloating.On an unknown date, the outcome of the faecal impaction and bloating were unknown.The reporter considered the faecal impaction and bloating to be probably related to new poligrip sa2.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, the patient experienced faecal impaction (seriousness: gsk medically significant) and abdominal bloating (seriousness: non-serious).He was using new poligrip sa2.He swallowed dissolved products.Due to abdominal bloating, he took ct scan, and faecal impaction was noted in the upper intestine.The physician indicated lack of exercise.On an unknown date, the outcome of the faecal impaction and abdominal bloating were unknown.No further information is expected.[reporter's comment] the patient himself guessed poligrip was causative.

• Brand Name: NEW POLIGRIP SA2
• 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: 18158421
• MDR Text Key: 328355105
• Report Number: 3003721894-2023-00197
• 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: 11/02/2023

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: 11/02/2023
• Initial Date FDA Received: 11/17/2023
• 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: 80 YR
• Patient Sex: Male