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

Lot Number UNKNOWN

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

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

I couldn't use them before because i would choke on them.[choking].Case description: this case was reported by a consumer and described the occurrence of choking in a (b)(6) female patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip for denture wearer.Co-suspect products included double salt dental adhesive cream (super poligrip (unspecified zinc free variant)) cream for product used for unknown indication.Concomitant products included no therapy.On an unknown date, the patient started super poligrip comfort seal strips and super poligrip (unspecified zinc free variant).On an unknown date, an unknown time after starting super poligrip comfort seal strips and super poligrip (unspecified zinc free variant), the patient experienced choking (serious criteria gsk medically significant) and gagging.The action taken with super poligrip comfort seal strips was unknown.On an unknown date, the outcome of the choking and gagging were unknown.The reporter considered the choking to be related to super poligrip comfort seal strips.The reporter considered the gagging to be related to super poligrip (unspecified zinc free variant).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Adverse event information was received via call on 09 december 2019.The consumer reported that "super polgirip strips, i bought them to put it on my bottom partials and they did pretty well when i eat.They were out of my mouth in the morning.Did they dissolve or what? i tried some other product of poligrip and it made me gag.Would put someone on the phone that speaks english? i brought these poligrip strips, for my lower dentures and i tried them before for the upper.I couldn't use them before because i would choke on them.So i used them for the bottom and when i woke up this morning it would be gone.Are they dissolving or what? i want to understand if it's suppose to dissolve or am i swallowing them.This was years ago.".

• Brand Name: SUPER POLIGRIP COMFORT SEAL STRIPS
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): KYOWA LTD IZUMISANO FACTORY; zumisano-city; osaka; JA
• Manufacturer Contact: po box 13398; research triangle park,; 8888255249
• MDR Report Key: 9558752
• MDR Text Key: 175225307
• Report Number: 3004699328-2019-00023
• Device Sequence Number: 1
• Product Code: KOL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/09/2019
• 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