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

Lot Number K876

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

Patient Problem Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Every time i put it in, i start throwing up.[vomiting].I bought the twin tube to try it i got deathly sick [sickness].Case description: this case was reported by a consumer via call center representative and described the occurrence of vomiting in a (b)(6) year-old female patient who received double salt dental adhesive cream (super poligrip extra care (zinc free formula)) cream (batch number k876, expiry date 31st may 2023) for denture wearer.On (b)(6) 2020, the patient started super poligrip extra care (zinc free formula).On an unknown date, less than a week after starting super poligrip extra care (zinc free formula), the patient experienced vomiting (serious criteria life threatening) and sickness (serious criteria life threatening).The action taken with super poligrip extra care (zinc free formula) was unknown.On an unknown date, the outcome of the vomiting was recovered/resolved and the outcome of the sickness was unknown.The reporter considered the vomiting and sickness to be related to super poligrip extra care (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 details, adverse event information was received via call center representative (phone) on 30 december 2020.Consumer called in about super poligrip extra care (zinc free formula) and reported that, "super strong all day long poligrip adhesive.I bought the twin tube to try it i got deathly sick.Every time i put it in, i start throwing up.I thought i put too much in i tried a few days putting less in but it didn't make a difference.I used it about a week ago monday.I only used it 3 times.Super poligrip extra care twin pack 2.2oz lot was k876 and expiry date 31 may 2023 i would like a refund.".

• Brand Name: SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)
• 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: 11181144
• MDR Text Key: 230468093
• Report Number: 3003721894-2021-00001
• 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: 12/30/2020

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
• Device Expiration Date: 05/31/2023
• Device Lot Number: K876
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/15/2021
• 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): Life Threatening
• Patient Age: 81 YR