MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA); DENTURE CLEANSER

Lot Number ADGR

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

Patient Problem Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Mfr report #: is associated with argus case (b)(4).

Event Description

I had thrush and a serious yeast infection [yeast infection].I had thrush and a serious yeast infection [thrush].I've also been dehydrated.[dehydration].Case description: this case was reported by a consumer via call center representative and described the occurrence of yeast infection in a (b)(6)-year-old male patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number ad6r, expiry date unknown) for denture wearer.Concomitant products included no therapy.On an unknown date, the patient started super poligrip original (zinc free formula).On an unknown date, an unknown time after starting super poligrip original (zinc free formula), the patient experienced yeast infection (serious criteria gsk medically significant and other: as per reporter), thrush and dehydration.On an unknown date, the outcome of the yeast infection, thrush and dehydration were unknown.It was unknown if the reporter considered the yeast infection, thrush and dehydration to be related to super poligrip original (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 center representative on (b)(6) 2020.Consumer reported that, "i have been using poligrip for years, going through 2 tubes a week.I see it says it should last 7 to 8 weeks i had thrush and a serious yeast infection.Can the poligrip cause that? can it cause dehydration? i've also been dehydrated".Follow up information was received on (b)(6) 2019 via returned consumer authorization form.Consumer had not provided physicians contact information.Consumer provide product lot number adgr having expiration date 31 july 2022.Lot number was updated in the case.

• Brand Name: SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 9963767
• MDR Text Key: 196915032
• Report Number: 3003721894-2020-00087
• 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: 03/03/2020

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
• Device Expiration Date: 07/31/2022
• Device Lot Number: ADGR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/15/2020
• 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: 56 YR