MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-02-15 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[100241535]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[100241536]
Dentist reported that the patient started whitening on (b)(6) 2018. On (b)(6) 2018 the patient woke up with puffy/swollen lips. Dentist immediately advised the patient to discontinue all kor products until he had a chance to speak with evolve dental. Advised dentist to inform the patient to discontinue use of the kor desensitizer permanently. Also, recommended that the patient try the new kor complete desensitizer, once the patient's symptoms have subsided and she is back to feeling normal. Followed up with dentist on (b)(6) 2018, who reported that the patient returned to normal after 7 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2018-00009 |
| MDR Report Key | 7275762 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-15 |
| Date of Report | 2018-01-16 |
| Date of Event | 2018-01-13 |
| Date Mfgr Received | 2018-01-16 |
| Date Added to Maude | 2018-02-15 |
| 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 | 2018-02-15 |
| 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 | 2018-02-15 |