MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for SUPER POLIGRIP COMFORT SEAL STRIPS manufactured by Kyowa, Ltd..
[80251636]
Mfr 3004699328-2017-00011 is associated with argus case (b)(4), super poligrip comfort seal strips.
Patient Sequence No: 1, Text Type: N, H10
[80251637]
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".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004699328-2017-00011 |
| MDR Report Key | 6720005 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-07-12 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-07-21 |
| Date Added to Maude | 2017-07-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUPER POLIGRIP COMFORT SEAL STRIPS |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2017-07-17 |
| Lot Number | 57056XC |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYOWA, LTD. |
| Manufacturer Address | 4-81, TSURUHARA 4-CHOME IZUMISANO-CITY, 598-0071 JA 598-0071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-17 |