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

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Respiratory Distress (2045); Vomiting (2144); Burning Sensation (2146); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The report # 3003721894-2018-00257 is associated with (b)(4), super poligrip free denture adhesive cream.

Event Description

I swallow some of it [accidental device ingestion].I swallow some of it and made my stomach upset [upset stomach].Gag [gagging.] it seems like i'm kind of allergic to super poligrip [allergic reaction].My gums started to burn [burning gum].I was coughing so hard [cough].My nose bled [epistaxis].I felt like there's a lot of hair particles that made me scratch my nose [nasal irritation].Case description: this case was reported by a consumer and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (super poligrip free denture adhesive cream) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.On (b)(6) 2018, the patient started super poligrip free denture adhesive cream.On an unknown date, several hours after starting super poligrip free denture adhesive cream, the patient experienced accidental device ingestion (serious criteria gsk medically significant), upset stomach, gagging, allergic reaction, burning gum, cough, epistaxis, nasal irritation and product complaint.On an unknown date, the outcome of the accidental device ingestion, upset stomach, gagging, allergic reaction, burning gum, cough, epistaxis, nasal irritation and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion, burning gum, cough, epistaxis and nasal irritation to be related to super poligrip free denture adhesive cream.The reporter considered the upset stomach, gagging and allergic reaction to be related to super poligrip free denture adhesive cream.Additional information adverse event information was received via call on (b)(4) 2018.The consumer reported that, "it seems like i am kind of allergic to super poligrip (zinc free).I used it just yesterday and couple of hours after, my gums started to burn, i was coughing so hard, i swallow some of it and made my stomach upset and gag.I felt like there's a lot of hair particles that made me scratch my nose and bled.Also the product did not hold." action taken unknown".Adverse event revision information was received (b)(4) 2018.The case was not associated with event of "product complaint".The event "product complaint" coded in the initial report were removed.

• Brand Name: SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; knockbrack, dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709
• MDR Report Key: 7723865
• MDR Text Key: 115189797
• Report Number: 3003721894-2018-00257
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 07/16/2018
• 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