MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA); DENTURE ADHESIVE

Lot Number EK4R

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

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Argus case number (b)(4).

Event Description

Maybe that's why i have kidney stones [renal stone], so i don't know if i'm swallowing it or not what's going on? [accidental device ingestion], i don't think it's safe i think it's causing indigestion [indigestion].Case description: this case was reported by a consumer and described the occurrence of renal stone in a (b)(6) male patient who received double salt dental adhesive cream (super poligrip ultra fresh (zinc free formula)) cream (batch number ek4r, expiry date unknown) for denture wearer.On an unknown date, the patient started super poligrip ultra fresh (zinc free formula).On an unknown date, an unknown time after starting super poligrip ultra fresh (zinc free formula), the patient experienced renal stone (serious criteria gsk medically significant), accidental device ingestion (serious criteria gsk medically significant) and indigestion.The action taken with super poligrip ultra fresh (zinc free formula) was unknown.On an unknown date, the outcome of the renal stone, accidental device ingestion and indigestion were unknown.It was unknown if the reporter considered the renal stone, accidental device ingestion and indigestion to be related to super poligrip ultra fresh (zinc free formula).Additional information: adverse event information was received via call on (b)(6) 2019.The consumer reported that, "some time when i put the super poligrip on it stick to the roof of my mouth and other times , there is nothing there.So i don't know if i'm swallowing it or not what's going on? i have the super poligrip ultra fresh, the lot looks like ex48.It's ek4r.When i don't eat a lot all day, it's there, but what i eat it not there.I take them out every night and soak them in the polident overnight.I don't know where it goes.Maybe that's why i have kidney stones.I don't think that's safety.I don't think it's safe, i think it's causing indigestion.".

Manufacturer Narrative

Argus case (b)(4).

Event Description

Case description: this case was reported by a consumer and described the occurrence of renal stone in a 68-year-old male patient who received double salt dental adhesive cream (super poligrip ultra fresh (zinc free formula)) cream (batch number ek4r, expiry date unknown) for denture wearer.On an unknown date, the patient started super poligrip ultra fresh (zinc free formula).On an unknown date, an unknown time after starting super poligrip ultra fresh (zinc free formula), the patient experienced renal stone (serious criteria gsk medically significant), accidental device ingestion (serious criteria gsk medically significant) and indigestion.The action taken with super poligrip ultra fresh (zinc the outcome of the renal stone, accidental device ingestion and indigestion were unknown.It was unknown if the reporter considered the renal stone, accidental device ingestion and indigestion to be related to super poligrip ultra fresh (zinc free formula).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information, adverse event information was received via call on (b)(6) 2019.The consumer reported that, "some time when i put the super poligrip on it stick to the roof of my mouth and other times , there is nothing there.So i don't know if i'm swallowing it or not what's going on? i have the super poligrip ultra fresh, the lot looks like ex48.It's ek4r.When i don't eat a lot all day, it's there ,but what i eat its not there.I take them out ever night and soak them in the polident overnight.I don't know where it goes.Maybe that's why i have kidney stones.I don't think that's safety.I don't think it's safe i think it's causing indigestion.' follow up adverse event information was received via authorization form on 17 april 2019.Consumer provided physicians details.The two lot number (98099xi, 62000000007695) for super poligrip ultra fresh (zinc free formula) was added into the case.

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Case description: this case was reported by a consumer and described the occurrence of renal stone in a 68-year-old male patient who received double salt dental adhesive cream (super poligrip ultra fresh (zinc free formula) cream (batch number ek4r, expiry date unknown) for denture wearer.On an unknown date, the patient started super poligrip ultra fresh (zinc free formula).On an unknown date, an unknown time after starting super poligrip ultra fresh (zinc free formula), the patient experienced renal stone (serious criteria gsk medically significant), accidental device ingestion (serious criteria gsk medically significant) and indigestion.The action taken with super poligrip ultra fresh (zinc free formula) was unknown.On an unknown date, the outcome of the renal stone, accidental device ingestion and indigestion were unknown.It was unknown if the reporter considered the renal stone, accidental device ingestion and indigestion to be related to super poligrip ultra fresh (zinc free formula).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information, adverse event information was received via call on (b)(6) 2019.The consumer reported that, "some time when i put the super poligrip on it stick to the roof of my mouth and other times , there is nothing there.So i don't know if i'm swallowing it or not what's going on? i have the super poligrip ultra fresh, the lot looks like ex48.It's ek4r.When i don't eat a lot all day, it's there ,but what i eat it not there.I take them out ever night and soak them in the polident overnight.I don't know where is goes.Maybe that's why i have kidney stones.I don't think that's safety.I don't think it's safe i think it's causing indigestion.' follow up adverse event information was received via authorization form on 17 april 2019.Consumer provided physicians details.The two lot number: (98099xi, 62000000007695) for super poligrip ultra fresh (zinc free formula) was added into the case.Follow up information was received on 11 june 2019 via adverse event reporting (aer) form by physician.Physician medically confirmed the reported information.

• Brand Name: SUPER POLIGRIP ULTRA FRESH (ZINC FREE FORMULA)
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, co. waterford ; EI
• MDR Report Key: 8469273
• MDR Text Key: 140606961
• Report Number: 3003721894-2019-00086
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

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: Lay User/Patient
• Device Lot Number: EK4R
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 04/17/2019; 06/11/2019
• Supplement Dates FDA Received: 05/15/2019; 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR