MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP SA; DENTURE ADHESIVE

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

Patient Problem Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Gastrointestinal candidiasis [gastric candidiasis].Case description: this case was reported by a dentist via sales rep and described the occurrence of gastric candidiasis in a (b)(6) old male patient who received double salt dental adhesive cream (poligrip) cream for denture wearer.Concurrent medical conditions included denture wearer and poor oral hygiene.On an unknown date, the patient started poligrip.On an unknown date, an unknown time after starting poligrip, the patient experienced gastric candidiasis (serious criteria gsk medically significant).On an unknown date, the outcome of the gastric candidiasis was unknown.It was unknown if the reporter considered the gastric candidiasis to be related to poligrip.[clinical course].Indication: better fitting of the artificial dentures.Present illness: poor oral hygiene.On unknown date - the patient used an adequate dose of poligrip as a daily dose.On unknown date - by endoscopy, the physician pointed out that the patient's stomach was molded (seriousness: gsk medically significant), and asked the patient whether he was using any denture adhesive.As of (b)(6) 2019 - the patient was still using the denture adhesive.

Manufacturer Narrative

Argis case (b)(4).

Event Description

Case description: this case was reported by a dentist via sales rep and described the occurrence of gastric candidiasis in a 7-decade-old male patient who received double salt dental adhesive cream (poligrip) cream for denture wearer.Concurrent medical conditions included denture wearer and poor oral hygiene.On an unknown date, the patient started poligrip.On an unknown date, an unknown time after starting poligrip, the patient experienced gastric candidiasis (serious criteria gsk medically significant).On an unknown date, the outcome of the gastric candidiasis was unknown.It was unknown if the reporter considered the gastric candidiasis to be related to poligrip.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course] indication: better fitting of the artificial dentures.Present illness: poor oral hygiene.On unknown date the patient used an adequate dose of poligrip as a daily dose.On unknown date: by endoscopy, the physician pointed out that the patient's stomach was molded (serious criteria gsk medically significant and other: gsk medically significant), and asked the patient whether he was using any denture adhesive.As of (b)(6) 2019: the patient was still using the denture adhesive.Follow-up information received from the reporting dentist on (b)(6) 2019.[clinical course] suspect product: new poligrip sa (double salt dental adhesive cream) cream.On unknown date: the dentist got samples of new poligrip sa; therefore, he/she provided them to the patient.Since the dentist instructed the patient to apply a small amount of the product, he/she presumed that the actual amount used by the patient was also a small amount.Although the denture adhesive the patient was actually using could not be confirmed, but the dentist presumed that the patient was using new poligrip sa recommended by the dentist.Follow-up information received from the reporting pharmacist on (b)(6) 2019.[clinical course] on an unknown date: the outcome of the gastric candidiasis was unknown because the patient had not visited the pharmacy.It was unknown when the patient would visit the pharmacy.No further information will be provided due to the refusal of the reporting dentist.

• Brand Name: NEW POLIGRIP SA
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 9198119
• MDR Text Key: 174506895
• Report Number: 3003721894-2019-00256
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2019

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: No Information
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR