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

Lot Number 1518171

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Date 09/13/2021

Event Type  Injury  

Event Description

They choked me, it got in my throat, it was choking me [choking].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) female patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number 1518171, expiry date 29th february 2024) for denture wearer.This case was associated with a product complaint.On (b)(6) 2021, the patient started super poligrip comfort seal strips.On (b)(6) 2021, an unknown time after starting super poligrip comfort seal strips, the patient experienced choking (serious criteria gsk medically significant and other: gsk medically significant).On an unknown date, the patient experienced product complaint.The action taken with super poligrip comfort seal strips was unknown.On (b)(6) 2021, the outcome of the choking was recovered/resolved.On an unknown date, the outcome of the product complaint was unknown.The reporter considered the choking 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 was received from consumer via call centre representative (phone) on (b)(6) 2021.The consumer reported, "super strong all day hold adhesive strips.40 strips.Number 1 they don't work and number 2 they are dangerous.They choked me this is dangerous.Did anyone else call about this.I just cant believe i choked off this.These are not safe.Its been quite awhile by the receipt i see september of when i bought them and then i forgot them.I end up having medical things happen and out of town so then i forgot about them.I cant remember the date had to be in september.I just used them just once.It really scared me.It got in my throat and i didn't know how to get it out.It was choking me." follow up information was received from quality assurance (qa) department on 29dec2021 regarding complaint (b)(4) (pqc number) and (b)(4) (issue number) for lot number 1518171.Investigation evaluation: each batch of strips are tested for all required quality characteristics during manufacturing.Only approved materials are used in any lot of poligrip comfort strips.Any lot which exhibits defects or improper performance would fail such testing and would not be released to the market.The adhesive used for all poligrip comfort strips, regardless of type, has not changed in over fourteen years.Laboratory test reports for lot in question confirms the retain samples had all test results within nominal range of the specification limits.Lot 1518171 is a valid lot packaged in (b)(6) 2021.Without samples from the complaint, scapa is unable to further investigate to determine root cause or confirmation of defect stated.There is not enough evidence to substantiate the complaint that scapa manufacturing is the cause for the defect stated.Based on the investigation performed by the site the complaint was concluded unsubstantiated.

Manufacturer Narrative

Argus case id: (b)(4).

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

They choked me, it got in my throat, it was choking me [choking].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a (b)(6) female patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number 1518171, expiry date 29th february 2024) for denture wearer.This case was associated with a product complaint.On (b)(6) 2021, the patient started super poligrip comfort seal strips.On (b)(6) 2021, an unknown time after starting super poligrip comfort seal strips, the patient experienced choking (serious criteria gsk medically significant and other: gsk medically significant).On an unknown date, the patient experienced product complaint.The action taken with super poligrip comfort seal strips was unknown.On (b)(6) 2021, the outcome of the choking was recovered/resolved.On an unknown date, the outcome of the product complaint was unknown.The reporter considered the choking to be related to super poligrip comfort seal strips.Additional details: adverse event information was received from consumer via call centre representative (phone) on (b)(6) 2021.The consumer reported, "super strong all day hold adhesive strips.40 strips.Number 1 they don't work and number 2 they are dangerous.They choked me this is dangerous.Did anyone else call about this.I just cant believe i choked off this.These are not safe.Its been quite awhile by the receipt i see september of when i bought them and then i forgot them.I end up having medical things happen and out of town so then i forgot about them.I cant remember the date had to be in september.I just used them just once.It really scared me.It got in my throat and i didn't know how to get it out.It was choking me." follow up information was received from quality assurance (qa) department on 29dec2021 regarding complaint (b)(4) (pqc number) and (b)(4) (issue number) for lot number 1518171.Investigation evaluation: each batch of strips are tested for all required quality characteristics during manufacturing.Only approved materials are used in any lot of poligrip comfort strips.Any lot which exhibits defects or improper performance would fail such testing and would not be released to the market.The adhesive used for all poligrip comfort strips, regardless of type, has not changed in over fourteen years.Laboratory test reports for lot in question confirms the retain samples had all test results within nominal range of the specification limits.Lot 1518171 is a valid lot packaged in (b)(6) 2021.Without samples from the complaint, scapa is unable to further investigate to determine root cause or confirmation of defect stated.There is not enough evidence to substantiate the complaint that scapa manufacturing is the cause for the defect stated.Based on the investigation performed by the site the complaint was concluded unsubstantiated.

• Brand Name: SUPER POLIGRIP COMFORT SEAL STRIPS
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): KYOWA LTD IZUMISANO FACTORY; izumisano, osaka ; JA
• Manufacturer Contact: po box 13398; research triangle park,, NC 27709 ; 8888255249
• MDR Report Key: 13176158
• MDR Text Key: 286238567
• Report Number: 3004699328-2021-00010
• 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: 12/21/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Lot Number: 1518171
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Female