MAUDE Adverse Event Report: KYOWA, LTD. SUPER POLIGRIP COMFORT SEAL STRIPS; DENTURE ADHESIVE

Lot Number 57056XC

Device Problem Material Deformation (2976)

Patient Problem Choking (2464)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

Mfr 3004699328-2017-00011 is associated with argus case (b)(4), super poligrip comfort seal strips.

Event Description

Almost choked my husband [choking], gagged him [gagging].Case description: this case was reported by a consumer and described the occurrence of choking in a (b)(6) male patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number 57056xc, expiry date unknown) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.On (b)(6) 2017, the patient started super poligrip comfort seal strips.On (b)(6) 2017, less than a day after starting super poligrip comfort seal strips, the patient experienced choking (serious criteria gsk medically significant) and gagging.On an unknown date, the patient experienced product complaint.Super poligrip comfort seal strips was discontinued (dechallenge was positive).On (b)(6) 2017, the outcome of the choking and gagging were recovered/resolved.On an unknown date, the outcome of the product complaint was unknown.The reporter considered the choking and gagging to be related to super poligrip comfort seal strips.Additional details, adverse event information was received on 12 july 2017.Consumer reported her husband tried super poligrip comfort seal strips 40ct just once.Consumer reported that "we bought for my husband.The first time he used this it held well.But within a matter of 3 hours the strips melted to slime and almost choked my husband.Stuff started oozing, went down his throat and gagged him.What product do you have that will not be too oozy/messy for my husband".

Manufacturer Narrative

3004699328-2017-00011 is associated with argus case (b)(4), super poligrip comfort seal strips.Complaint issue received on (b)(6)2017 for issue number (b)(4): the lot number was invalid and no sample was returned for this complaint so no further investigation was available.This complaint is considered unsubstantiated.

Event Description

Case description: this case was reported by a consumer and described the occurrence of choking in a 67-year-old male patient who received polyethylene oxide, sodium carboxymethylcellulose (super poligrip comfort seal strips) strip (batch number 57056xc, expiry date unknown) for denture wearer.This case was associated with a product complaint.Concomitant products included no therapy.On (b)(6)2017, the patient started super poligrip comfort seal strips.On (b)(6)2017, less than a day after starting super poligrip comfort seal strips, the patient experienced choking (serious criteria gsk medically significant) and gagging.On an unknown date, the patient experienced product complaint.Super poligrip comfort seal strips was discontinued (dechallenge was positive).On (b)(6)2017, the outcome of the choking and gagging were recovered/resolved.On an unknown date, the outcome of the product complaint was unknown.The reporter considered the choking and gagging 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 on (b)(6)2017.Consumer reported her husband tried super poligrip comfort seal strips 40ct just once.Consumer reported that "we bought for my husband.The first time he used this it held well.But within a matter of 3 hours the strips melted to slime and almost choked my husband.Stuff started oozing, went down his throat and gagged him.What product do you have that will not be too oozy/messy for my husband".Follow up information was received on (b)(6)2017 from quality assurance (qa) department regarding complaint number (b)(4) (issue number) for lot number 57056xc (invalid lot number).The investigation report included that, the product sample was not received.No further investigation were available due to lack of information and no lot numbers or returned products.As all products met all release requirements at release, this was an unsubstantiated complaint, would not be derived from the production.

• Brand Name: SUPER POLIGRIP COMFORT SEAL STRIPS
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): KYOWA, LTD.; 4-81, tsuruhara 4-chome; izumisano-city, 598-0 071; JA 598-0071
• MDR Report Key: 6720005
• MDR Text Key: 80251636
• Report Number: 3004699328-2017-00011
• 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,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 57056XC
• Date Manufacturer Received: 07/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Age: 67 YR