MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-07 for SUPER POLIGRIP COMFORT SEAL STRIPS manufactured by Kyowa Ltd Izumisano Factory.
[175225307]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[175225308]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004699328-2019-00023 |
| MDR Report Key | 9558752 |
| Report Source | CONSUMER |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-09 |
| Date Mfgr Received | 2019-12-09 |
| Date Added to Maude | 2020-01-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 RESEARCH TRIANGLE PARK, |
| Manufacturer City | NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER POLIGRIP COMFORT SEAL STRIPS |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2020-01-07 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KYOWA LTD IZUMISANO FACTORY |
| Manufacturer Address | ZUMISANO-CITY OSAKA JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-07 |