MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-21 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[133710765]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[133710768]
Dental office reported that patient completed take home whitening and started her whitening maintenance (with hema desensitizer) in october. When the patient whitened the one night in november (not sure of the exact date) she woke up the next morning with puffy/swollen lips. Requested dental assistant to inform the patient to permanently discontinue use of the k? R desensitizer (the patient had already done so, and she hasn't whitened since the possible reaction). The patient went to see her dentist and general practitioner, who prescribed her benadryl and a steroid to help with inflammation and other symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2019-00002 |
| MDR Report Key | 8263537 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-21 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-01-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-01-21 |
| Catalog Number | 10-1012 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-01-21 |