MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT); DOUBLE SALT DENTAL ADHESIVE CREAM

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

Patient Problem Death (1802)

Event Type  malfunction  

Manufacturer Narrative

Argus case (b)(4).

Event Description

She already passed away [unknown cause of death].It made me really funny and dizzy when i first used [dizziness].It made me feel really funny and dizzy [weird feeling].Case description: this case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a female patient who received double salt dental adhesive cream (super poligrip (unspecified zinc free variant)) cream (batch number unk, expiry date unknown) for product used for unknown indication.Concomitant products included no therapy.On an unknown date, the patient started super poligrip (unspecified zinc free variant).On an unknown date, an unknown time after starting super poligrip (unspecified zinc free variant), the patient experienced unknown cause of death (serious criteria death, gsk medically significant and other: gsk medically significant), dizziness and weird feeling.The action taken with super poligrip (unspecified zinc free variant) was unknown.On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the dizziness and weird feeling were unknown.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the unknown cause of death to be related to super poligrip (unspecified zinc free variant).The reporter considered the dizziness and weird feeling to be related to super poligrip (unspecified zinc free variant).Additional details, adverse event information was received via call center representative on 26 may 2020.The consumer reported "i used your product poligrip and i like it very much.You have a new product that come out that has a tip on it.It is purple.I use this gold one.I would like, want to know how come we put a tip on the gold one too, all of it.They are really nice.The new one that you all got out, it is really nice and smooth.The other one kind makes it gummy and the tip would help would this older kind of tube, too.I think it would be great to have that with super poligrip for all of them instead of just one product.I think people would like bigger tubes, they need a lot of it, they need the big ones like a toothpaste.It is gummy when it comes out and it is because of the tubing.They have the lead and everything.It is wide and goofy when it comes out.And it spreads all over the place where it need to be.It makes a mess when you put it in your teeth.(do you mean, it is dispensing more than what you need) i am glad you do not have that pink anymore.I started with it and that stuff really made me really dizzy.When i first started using it, there was zinc in there and i did not realized it was that strong.It made me feel really funny and dizzy when i first used it, back then when it still has zinc.I first used it when i was (b)(6) years old.I had a friend that had the same feeling about it.I don't know her last name, she already passed away".This case was linked with (b)(4) (reporters case).

Manufacturer Narrative

Argus case (b)(4).

Event Description

It made me really funny and dizzy when i first used [dizziness], it made me feel really funny and dizzy [weird feeling].Case description: this case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a female patient who received double salt dental adhesive cream (super poligrip (unspecified zinc free variant)) cream (batch number unk, expiry date unknown) for product used for unknown indication.Concomitant products included no therapy.On an unknown date, the patient started super poligrip (unspecified zinc free variant).On an unknown date, an unknown time after starting super poligrip (unspecified zinc free variant), the patient experienced unknown cause of death (serious criteria death, gsk medically significant and other: gsk medically significant), dizziness and weird feeling.The action taken with super poligrip (unspecified zinc free variant) was unknown.On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the dizziness and weird feeling were unknown.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the unknown cause of death to be related to super poligrip (unspecified zinc free variant).The reporter considered the dizziness and weird feeling to be related to super poligrip (unspecified zinc free variant).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 on 26 may 2020.The consumer reported "i used your product poligrip and i like it very much.You have a new product that come out that has a tip on it.It is purple.I use this gold one.I would like, want to know how come we put a tip on the gold one too, all of it.They are really nice.The new one that you all got out, it is really nice and smooth.The other one kind makes it gummy and the tip would help would this older kind of tube, too.I think it would be great to have that with super poligrip for all of them instead of just one product.I think people would like bigger tubes, they need a lot of it, they need the big ones like a toothpaste.It is gummy when it comes out and it is because of the tubing.They have the lead and everything.It is wide and goofy when it comes out.And it spreads all over the place where it need to be.It makes a mess when you put it in your teeth.(do you mean, it is dispensing more than what you need) i am glad you do not have that pink anymore.I started with it and that stuff really made me really dizzy.When i first started using it, there was zinc in there and i did not realized it was that strong.It made me feel really funny and dizzy when i first used it, back then when it still has zinc.I first used it when i was 50 years old.I had a friend that had the same feeling about it.I don't know her last name, she already passed away".This case was linked with (b)(4) (reporters case).Follow-up received upon internal review on 5 june 2020, event of death was removed from the case.Comment: downgrade report.

• Brand Name: SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT)
• Type of Device: DOUBLE SALT DENTAL ADHESIVE CREAM
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford
• MDR Report Key: 10134103
• MDR Text Key: 194509953
• Report Number: 3003721894-2020-00158
• 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
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) NO THERAPY (NO THERAPY); 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Death; Other