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 Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Foreign body in throat [foreign body in throat].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 throat 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 foreign body in throat (serious criteria gsk medically significant) and device use error.On an unknown date, the outcome of the foreign body in throat and device use error were unknown.It was unknown if the reporter considered the foreign body in throat and device use error to be related to new poligrip sa.[clinical course]: on an unknown date the patient removed his upper complete dentures after every meal to wash them well, applied new poligrip sa to them, and then put them back in his mouth.When he took out the dentures before bedtime, he could not get rid of some adhesive cream from his mouth.When he slept with the adhesive left in his mouth, it then melted and was caught in the throat (seriousness: gsk medically significant).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: 10152761
• MDR Text Key: 201006401
• Report Number: 3003721894-2020-00135
• 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: 05/18/2020

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
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/15/2020
• 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
• Patient Age: 80 YR