MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-05 for EVERSTICK 44786 900831 manufactured by Stick Tech Ltd..
[37543363]
A female patient alleged to have suffered severe pain after splinting treatment of a dental element with the above mentioned product (splinting fiber), used in conjunction with an adhesive from another manufacturer (transbond supreme, 3m, lot not available). The reaction consisted in pain, mouth dryness, altered taste and altered saliva consistency, taste of glue in the mouth. Patient has asked the doctor the re-treatment of the splinting, and after under-gengiva excess adhesive removal, has been redirected to another doctor. It is unclear if the patient has contacted further professionals ad if she has been subject to further therapy. Dentist advised to consult an allergologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2016-00001 |
| MDR Report Key | 5412592 |
| Date Received | 2016-02-05 |
| Date of Report | 2016-02-04 |
| Date of Event | 2015-11-10 |
| Date Facility Aware | 2016-01-15 |
| Report Date | 2016-02-04 |
| Date Reported to FDA | 2016-02-04 |
| Date Reported to Mfgr | 2016-02-03 |
| Date Added to Maude | 2016-02-05 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVERSTICK |
| Generic Name | EVERSTICK ORTHO |
| Product Code | DYT |
| Date Received | 2016-02-05 |
| Model Number | 44786 |
| Catalog Number | 900831 |
| Lot Number | 20150204A |
| Device Expiration Date | 2017-02-04 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STICK TECH LTD. |
| Manufacturer Address | LEMMINKAISENKATU 46 TURKU LANSI-SUOMEN LAANI, FI-20521 FI FI-20521 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-05 |