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 03/13/2020

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Hospitalisation [hospitalisation].Mastication disorder [mastication disorder].Foreign body in respiratory tract [foreign body in larynx].Productive cough [sputum].Case description: this case was reported by a consumer via call center representative and described the occurrence of hospitalisation in a (b)(6)-year-old male patient who received double salt dental adhesive cream (new poligrip sa) cream for denture wearer.The patient's past medical history included cerebral infarction and pneumonia.Concurrent medical conditions included denture wearer, living in nursing home and swallowing difficult.In 2019, the patient started new poligrip sa.On (b)(6) 2020, between 1 and 2 years after starting new poligrip sa, the patient experienced hospitalisation (serious criteria hospitalization).In 2020, the patient experienced foreign body in larynx and sputum.On an unknown date, the patient experienced mastication disorder.On (b)(6) 2020, the outcome of the hospitalisation was recovering/resolving.In 2020, the outcome of the foreign body in larynx and sputum were recovering/resolving.On an unknown date, the outcome of the mastication disorder was unknown.It was unknown if the reporter considered the hospitalisation, mastication disorder, foreign body in larynx and sputum to be related to new poligrip sa.[clinical course].Around spring in 2019, the patient started new poligrip sa.The patient was previously using the adhesive agent from other manufacturer.The patient was staying at the special elderly nursing home, where he was using new poligrip.The patient wore both the upper and lower whole dentures.Since he was told by the partner dental clinic at the facility to use new poligrip, he started it.The patient's medical history included cerebral infarction and swallowing difficult, thus he took chopped food with thickened liquid.He was also repeating pneumonia.Since the food was thickened the reporter thought the patient would not need the denture, but the patient hoped to "chew and eat".On (b)(6) 2020, the reason of the hospitalisation was unknown.During staying at the hospital, the reporter assisted the patient to eat, and noticed the patient spilled foods very often.Until (b)(6) 2020, the patient was staying at the hospital.On the same day, the outcome of the hospitalisation was recovering/resolving.On (b)(6) 2020, the patient went back to the special elderly nursing home and was fully assisted by the care giver.The care giver also said the patient spilled foods often.Between (b)(6) 2020 and (b)(6) 2020, the reporter was contacted from the facility that "new poligrip melted, adhered in the throat (seriousness: non-serious), mixed with sputum and stuck (seriousness: non-serious), and the patient needed suction", "when discontinued new poligrip, the symptom improved", "the staff at the facility would like to discontinue new poligrip".As of (b)(6) 2020, since the reporter did not have the product on him/her the detail was unknown, but the reporter thought the package was yellow-green (determined as new poligrip sa).The patient was also elder, so the reporter thought the cause was not only new poligrip.The denture was regularly adjusted by the facility and the partner dental clinic.It was unknown if the reporter considered melted new poligrip adhered in the throat, mixed with sputum and stuck to be related to new poligrip sa.[reporter's comment].It was unknown if the reporter considered melted new poligrip adhered in the throat, mixed with sputum and stuck to be related to new poligrip sa.The patient was also elder, so the reporter thought the cause was not only new poligrip.Other factors regarding to melted new poligrip adhered in the throat, mixed with sputum and stuck was elder.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: 10378469
• MDR Text Key: 207819350
• Report Number: 3003721894-2020-00128
• 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: 05/12/2020

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: 05/12/2020
• Initial Date FDA Received: 08/07/2020
• 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
• Patient Age: 82 YR