MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-02 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[96207229]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[96207230]
Dentist reported that patient started whitening about 7 days prior, and four days later, woke up with swollen lips and a mildly swollen face. The patient still has some swelling of the face and lips. Informed dentist to advise the patient to permanently discontinue use of the kor desensitizer permanently, and that once all symptoms subsided, the patient can resume whitening. Also, if need be, the patient can visit his general practitioner to help with any potential symptoms. Per follow-up with dentist on (b)(6) 2017, the patient's symptoms were gone within 3 days, and the patient started whitening again 3 days ago. Since discontinuing the kor desensitizer, the patient has had no further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2018-00001 |
| MDR Report Key | 7159238 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-02 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-11-24 |
| Date Mfgr Received | 2017-11-28 |
| Date Added to Maude | 2018-01-02 |
| 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 | 2018-01-02 |
| 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 | 2018-01-02 |