MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIGRIP; UNKNOWN

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

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

It went back of my throat [foreign body in throat].Had pain in my chest [chest pain].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a male patient who received unknown (poligrip (unknown)) unknown (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started poligrip (unknown).On an unknown date, an unknown time after starting poligrip (unknown), the patient experienced foreign body in throat (serious criteria gsk medically significant) and chest pain.The action taken with poligrip (unknown) was unknown.Unknown date, the outcome of the foreign body in throat and chest pain were unknown.It was unknown if the reporter considered the foreign body in throat and chest pain to be related to poligrip (unknown).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: the adverse event information was received from consumer via call center representative on 16-jun-2021.The consumer reported that"poligrip hi, couple of days ago i put some poligrip on my dentures but it went back of my throat and since then i have had pain in my chest.I called my doctor and they said to go phone ae but i can't get through to them.Is this the help line? okay i will call 111 and we carry on with this later.".

• Brand Name: POLIGRIP
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 12084412
• MDR Text Key: 269403643
• Report Number: 3003721894-2021-00224
• 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: 06/16/2021

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: 06/16/2021
• Initial Date FDA Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: No
• 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