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..
[100234650]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[100234671]
Dental office reported that their patient contacted them saying that after she began her at-home whitening, her lips swelled and felt numb. Office questioned if this could be a result of an allergy to hema in the k? R desensitizer. Confirmed that symptoms were consistent with a hema allergy and to have the patient stop using the desensitizer. Additionally, instructed dental office to have the patient clean her trays really well in cold water plus have her clean her tray case and anything that the desensitizer may have touched. Advised that when the patient is no longer symptomatic, she may resume whitening with the new k? R complete desensitizer which we sent to replace the hema desensitizer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2018-00008 |
| MDR Report Key | 7275760 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-02-15 |
| Date of Report | 2018-01-15 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-01-15 |
| 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 | DENTAL ASSISTANT |
| 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 |