MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-25 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[109356055]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[109356056]
Dentist reported that his patient came in for an in-office whitening only treatment on thursday ((b)(6) 2018). The patient did not whiten or desensitize at home, however a few days later, the patient's lips began to swell, and he contacted the dentist on (b)(6) 2018. Advised the dentist to instruct patient to permanently discontinue any use of the k? R desensitizer (if he is planning on whitening at home). Also, i informed dentist to advise the patient to visit his general practitioner if need be to help with any symptoms or inflammation. We also shipped out one bottle of in-office k? R complete desensitizer at no charge, which he could use going forward. Followed up with dental assistant, who report the patient returned to normal within 48 hours (all swelling had subsided).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2018-00013 |
| MDR Report Key | 7546855 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-25 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-04-22 |
| Date Mfgr Received | 2018-04-23 |
| Date Added to Maude | 2018-05-25 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA FJASTAD |
| Manufacturer Street | 5 VANDERBILT |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497130909 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K?R DESENSITIZER |
| Generic Name | AGENT, TOOTH BONDING, RESIN |
| Product Code | KLE |
| Date Received | 2018-05-25 |
| Catalog Number | 10-1012 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EVOLVE DENTAL TECHNOLOGIES, INC. |
| Manufacturer Address | 5 VANDERBILT IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-05-25 |