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 High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Diabetes mellitus [diabetes mellitus], hypoaesthesia oral [numbness of tongue], hypertension [hypertension], case description: this case was reported by a consumer via call center representative and described the occurrence of diabetes mellitus in a (b)(6) male patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sa.On an unknown date, an unknown time after starting new poligrip sa, the patient experienced diabetes mellitus (serious criteria gsk medically significant), numbness of tongue and hypertension.On an unknown date, the outcome of the diabetes mellitus, numbness of tongue and hypertension were unknown.It was unknown if the reporter considered the diabetes mellitus, numbness of tongue and hypertension to be related to new poligrip sa.[clinical course]: on an unknown date,the patient's upper teeth were dentures.Adhesives were essential things to him because he could not eat meals without using adhesive.The dentist recommended dental implant, but the patient refused it because it costs money.However, the tip of the tongue became numb when using adhesive.Therefore, he received a drug to remove the numbness at the department of otolaryngology.The symptom subsided when he used a drug probably for stomatitis.The physician also said that the cause was unknown.On an unknown date,the patient had hypertension and diabetes mellitus, and was taking a lot of prescribed drugs.Therefore, it may be an adverse reaction.No further information is expected.

• Brand Name: NEW POLIGRIP SA
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,; waterford, ; EI
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9503516
• MDR Text Key: 183295699
• Report Number: 3003721894-2019-00363
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2019

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: 11/28/2019
• Initial Date FDA Received: 12/20/2019
• 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: 87 YR