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 Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Anaphylactic shock [anaphylactic shock] rash [exanthema generalised] blister [blister] case description: this case was reported by a non-health professional via call center representative and described the occurrence of anaphylactic shock in a elderly 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 anaphylactic shock (serious criteria hospitalization and gsk medically significant), exanthema generalised (serious criteria hospitalization) and blister (serious criteria hospitalization).On an unknown date, the outcome of the anaphylactic shock, exanthema generalised and blister were unknown.The reporter considered the anaphylactic shock, exanthema generalised and blister to be probably related to new poligrip sa2.[clinical course] on an unknown date, the store staff reported that a male customer (about in his 70s or 80s) using new poligrip sa2 came to the store saying that he was just discharged from the hospital because he had experienced anaphylactic shock and was admitted to the hospital for 10 days.He had used new poligrip sa2 many times, but he experienced rash all over the body and blisters, and was emergently admitted to the hospital.The physician at the hospital said that new poligrip sa2 might be the cause and the physician would conduct research.The store staff assumed that he had used new poligrip sa2 for more than half a year.[reporter's comment] the physician at the hospital said that new poligrip sa2 might be the cause and the physician would conduct research.No further information will be provided due to the refusal of the reporting non-health professional.

• Brand Name: NEW POLIGRIP SA2
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 12665142
• MDR Text Key: 281275428
• Report Number: 3003721894-2021-00347
• 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: foreign
• Type of Report: Initial
• Report Date: 10/04/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/20/2021
• 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): Hospitalization; Other