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 No Code Available (3191)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Taste disorder [taste disorder].Pneumonia [acute pneumonia].Pyrexia [pyrexia].Coronavirus infection [coronavirus infection].Dyspnoea [dyspnoea].Device use error [device use error].Case description: this case was reported by a consumer via call center representative and described the occurrence of taste disorder in a (b)(6) male patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.The patient's past medical history included accident and rib fracture.Concurrent medical conditions included denture wearer.In 2020, the patient started new poligrip sa.On (b)(6) 2020, an unknown time after starting new poligrip sa, the patient experienced acute pneumonia (serious criteria hospitalization and gsk medically significant), pyrexia (serious criteria hospitalization) and coronavirus infection (serious criteria hospitalization).In 2020, the patient experienced dyspnoea.On an unknown date, the patient experienced taste disorder and device use error.The action taken with new poligrip sa was unknown.In 2020, the outcome of the acute pneumonia, pyrexia, coronavirus infection and dyspnoea were recovered/resolved.On an unknown date, the outcome of the taste disorder and device use error were unknown.It was unknown if the reporter considered the taste disorder, acute pneumonia, pyrexia, coronavirus infection, dyspnoea and device use error to be related to new poligrip sa.[clinical course] on an unknown date, when the patient was in his 40's, he started a post crown due to an accident and currently he had dentures.In (b)(6) 2020, the patient had rib fracture in this month, and it took about 4 months to heal.In (b)(6) 2020, the patient hadn't been to the dentist after having the dentures adjusted in (b)(6) this year.Until then, the dentures were adjusted once every two months, so no stabilizer was needed.On an unknown date, even while sleeping every night, he was keeping the dentures on with new poligrip sa.The dentures would not come off until morning and the throat would not clog.However, the stabilizer remained in the back of the throat like a sputum and he would have to spit it out when he woke up every morning.In addition, because of this condition, the water he drank first in the morning became less delicious (seriousness: non-serious).The patient could eat anything with new poligrip, and he was using it without any problems.On (b)(6) 2020, the patient experienced pyrexia (serious criteria hospitalization) due to acute pneumonia (serious criteria hospitalization and gsk medically significant), and was hospitalized for suspected coronavirus infection (serious criteria hospitalization) during the consecutive holidays.In 2020, about one and a half months after that, he had difficulty breathing due to the aftereffects of pneumonia (seriousness: non-serious).In 2020, currently it had recovered, but the physician told him he would die if he was infected with corona virus now, so he could not take a train to visit the dentist in (b)(6) from (b)(6).

• 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, NC 27709 ; 8888255249
• MDR Report Key: 10528123
• MDR Text Key: 206783669
• Report Number: 3003721894-2020-00242
• 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: consumer,foreign
• Type of Report: Initial
• Report Date: 08/17/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/14/2020
• 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): Hospitalization; Other
• Patient Age: 73 YR