MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-21 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[133707568]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[133707569]
Patient said she has "blisters on the inside of my upper & lower lips, particularly the lower. I believe that's because of the desensitizer so i stopped using it and switched to sensodyne just yesterday. " the patient confirmed that she has been using the k? R desensitizer with hema. Advised the patient to permanently discontinue using the k? R desensitizer with hema and to stop whitening indefinitely until she has a chance to see her dentist. Followed up with patient's dental office on (b)(6) 2019, office reported that the patient's blisters were gone and her swollen lips returned to normal after two days. The patient has since resumed whitening without using any k? R desensitizer, and she has had no issues since.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2019-00001 |
| MDR Report Key | 8263536 |
| Report Source | CONSUMER |
| Date Received | 2019-01-21 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-12-10 |
| Date Mfgr Received | 2018-12-11 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 |