MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP DENTURE ADHESIVE POWDER

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

I figured out why i was going into anaphylaxis, a sever allergic reaction [anaphylaxis].I figured out why i was going into anaphylaxis, a sever allergic reaction [allergic reaction].Case description: this case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a (b)(6)-year-old female patient who received denture adhesive powder-double salt (super poligrip denture adhesive powder) oral powder (batch number unk, expiry date unknown) for denture wearer.Concurrent medical conditions included latex allergy.Concomitant products included no therapy.On an unknown date, the patient started super poligrip denture adhesive powder.On an unknown date, an unknown time after starting super poligrip denture adhesive powder, the patient experienced anaphylaxis (serious criteria gsk medically significant and other: serious as per reporter) and allergic reaction (serious criteria other: serious as per reporter).The action taken with super poligrip denture adhesive powder was unknown.On an unknown date, the outcome of the anaphylaxis and allergic reaction were recovered/resolved.The reporter considered the anaphylaxis and allergic reaction to be related to super poligrip denture adhesive powder.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details, adverse event information was received via call center representative (phone) on 28 february 2020.Consumer called in about super poligrip denture adhesive powder and reported that, "i used to use a different product that was a power and you changed the formula and added cellulose gum.This is an issue because i have a latex allergy.I figured out why i was going into anaphylaxis, a severe allergic reaction.Yes the powered has the gum in it also.Do you have any products that are rubber latex free.".

• Brand Name: SUPER POLIGRIP DENTURE ADHESIVE POWDER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9882288
• MDR Text Key: 195243746
• Report Number: 3003721894-2020-00069
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2020

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: 02/28/2020
• Initial Date FDA Received: 03/26/2020
• 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): Other
• Patient Age: 51 YR