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

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

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

Argus case id (b)(4).

Event Description

Anaphylactic shock [anaphylactic shock], blister [bullae].Case description: this case was reported by a consumer via licensee and described the occurrence of anaphylactic shock in a (b)(6) female patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sa.On an unknown date, an unknown time after starting new poligrip sa, the patient experienced anaphylactic shock (serious criteria hospitalization and gsk medically significant) and bullae (serious criteria hospitalization).On an unknown date, the outcome of the anaphylactic shock and bullae were recovered/resolved.It was unknown if the reporter considered the anaphylactic shock and bullae to be related to new poligrip sa.[clinical course]: the patient, the reporter's mother, experienced anaphylactic shock (seriousness: gsk medically significant and hospitalization) by using new poligrip sa.She developed blisters (seriousness: hospitalization) on her arm(s), neck, and back after using new poligrip sa.She was hospitalized for one day.On an unknown date, the symptom was resolved after she discontinued using new poligrip sa.The physical abnormality (anaphylactic shock) and bullae on the arm(s), neck, and back were resolved.[reporter's comment]: (opinion by the physician) the physician was not sure what did not agree with the patient since the details on the ingredients of the drug were unknown until he/she asked the manufacturer.No further information is expected.

• Brand Name: NEW POLIGRIP SA
• 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: 9544911
• MDR Text Key: 183290767
• Report Number: 3003721894-2019-00376
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 12/06/2019

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: 12/06/2019
• Initial Date FDA Received: 01/03/2020
• 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
• Patient Age: 90 YR