MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD NEW POLIGRIP SA2; DENTURE ADHESIVE

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

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Foreign body in throat [foreign body in pharynx], oropharyngeal discomfort [pharynx strange sensation of], eructation [eructation], vomiting [vomiting], pharyngeal swelling [throat swelling], 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 foreign body in pharynx in a male patient who received double salt dental adhesive cream (new poligrip sa2) cream for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started new poligrip sa2.On (b)(6) 2020, an unknown time after starting new poligrip sa2, the patient experienced foreign body in pharynx (serious criteria gsk medically significant).On an unknown date, the patient experienced pharynx strange sensation of, eructation, vomiting, throat swelling, dyspnoea and device use error.The action taken with new poligrip sa2 was unknown.On an unknown date, the outcome of the foreign body in pharynx and pharynx strange sensation of were recovered/resolved and the outcome of the eructation, vomiting, throat swelling, dyspnoea and device use error were unknown.It was unknown if the reporter considered the foreign body in pharynx, pharynx strange sensation of, eructation, vomiting, throat swelling, dyspnoea and device use error to be related to new poligrip sa2.[clinical course]: on an unknown date, the patient was using new poligrip sa2 because he felt too painful to chew when wearing his denture which was just remade without new poligrip sa2.On an unknown date, the patient had been using new poligrip sa2 for years and experienced eructation (seriousness: non-serious) and vomiting (seriousness: non-serious) after meal in the daytime of hot days only in the summer every year.On an unknown date, the patient this time experienced strange feeling and foreign body sensation of throat for a while (seriousness: non-serious) in addition to those symptoms.The patient visited an otorhinolaryngology and was told that his throat was swollen (seriousness: non-serious).Chinese medicine was prescribed, but nothing changed.On (b)(6) 2020, the patient was told at a dental clinic that there was a white object in the back of his throat (serious criteria gsk medically significant).On (b)(6) 2020, the white object was removed with anesthesia to throat.The dentist told that the object was new poligrip sa2.The object was white and harder than new poligrip sa2 but thick.On an unknown date, the patient sometimes used too much new poligrip sa2, and it stuck out.Also, sometimes he did not remove the adhesive after removing his denture or keep the adhesive while sleeping.The patient sometimes had feeling of dyspnea while sleeping as he used the adhesive again after dinner.The dentist told that the adhesive should be used in small amount although it could not be helped to use it.The patient had no strange feeling or foreign body sensation after the object was removed.The outcome of the foreign body was stuck in throat and could not be removed, and strange feeling and foreign body sensation of throat were recovered/resolved.

• Brand Name: NEW POLIGRIP SA2
• 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: 10676737
• MDR Text Key: 216680537
• Report Number: 3003721894-2020-00284
• 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: 09/17/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/14/2020
• 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): Other