MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-13 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[136108973]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[136108974]
Dentist reported that his patient woke up with what appeared to be swollen lips and sores on the inside and corner of her mouth. The patient had only whitened at night twice (utilizing the k? R desensitizer with hema) before waking up with the swollen lips and sores. Requested dentist to inform the patient to discontinue use of the k? R desensitizer indefinitely. Followed up with dental office on feb. 5, 2019, who said the patient's swelling completely dissipated and all sores were gone within 24 hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2019-00003 |
| MDR Report Key | 8337551 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-15 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2019-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2019-02-13 |
| 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 | 2019-02-13 |