MAUDE Adverse Event Report: KYOWA LTD IZUMISANO FACTORY SUPER POLIGRIP COMFORT SEAL STRIPS; DENTURE ADHESIVE

Lot Number 20K0103

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

"it's obstructing my throat.[upper airway obstruction].It's not really comfortable.It's so gooey [oral discomfort].I keep coughing, and it's a really dry cough; it's nasty.[dry cough]." case description: this case was reported by a consumer via call center representative, and described the occurrence of upper airway obstruction in a female patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number 20k0103, expiry date unknown) for denture wearer.Concomitant products included no therapy.On an unknown date, the patient started super poligrip comfort seal strips.On an unknown date, an unknown time after starting super poligrip comfort seal strips, the patient experienced upper airway obstruction (serious criteria gsk medically significant and other: gsk medically significant), oral discomfort, and dry cough.The action taken with super poligrip comfort seal strips was unknown.On an unknown date, the outcome of the upper airway obstruction, and oral discomfort were unknown, and the outcome of the dry cough was not recovered/not resolved.The reporter considered the upper airway obstruction, and oral discomfort to be related to super poligrip comfort seal strips.It was unknown if the reporter considered the dry cough to be related to super poligrip comfort seal strips.This report is made by gsk without prejudice and does not imply any admission, or liability for the incident, or its consequences.Additional details, adverse event information received via call center representative on 22 september 2020.The consumer reported, "the first time i tried the poligrip adhesive strips.I never tried this before.I was using the denture paste.It's worse than the paste.The strip melts.It's not really comfortable.It's so gooey.I like the paste better.It's a lot of money.If you would like to refund me that's ok.I can send it back.It's not like sea-bond.It's obstructing my throat.When it dissolved i didn't know it was supposed to dissolve.It's so sticky.I keep coughing and it's a really dry cough and it's nasty." concomitant drug included unknown denture paste, sea bond.

• Brand Name: SUPER POLIGRIP COMFORT SEAL STRIPS
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): KYOWA LTD IZUMISANO FACTORY; izumisano-city, osaka ; JA
• MDR Report Key: 10689238
• MDR Text Key: 214736811
• Report Number: 3004699328-2020-00008
• Device Sequence Number: 1
• Product Code: KOL
• 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
• Type of Report: Initial
• Report Date: 09/22/2020

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
• Device Lot Number: 20K0103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/16/2020
• 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