MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-09 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[96812113]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[96812114]
Dentist reported that patient had to start and stop whitening because her gums were burning and her lip was swollen. She started and stopped twice and each time symptoms came back. Advised dentist to inform the patient to discontinue use of the k? R desensitizer permanently, and that once she returns to normal, she can resume whitening, as long as she does not use the kor desensitizer again. Sated that the patient can see her general practitioner to help with any symptoms or discomfort, and we shipped a bottle of the k? R complete desensitizer (does not contain hema) at no charge for the patient to try. Followed-up with dental office on (b)(6) 2018, they said the patient has since returned to normal. The patient resumed whitening this past week, and has been using the k? R complete desensitizer with no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2018-00004 |
| MDR Report Key | 7176860 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-09 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-11-20 |
| Date Mfgr Received | 2017-12-06 |
| Date Added to Maude | 2018-01-09 |
| 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 | 2018-01-09 |
| 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 | 2018-01-09 |