MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-15 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[97278920]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[97278921]
Dentist reported that patient had swollen lips after doing whitening maintenance with k? R 16% carbamide peroxide and the k? R hema desenstizer. She used the desensitizer during her initial whitening with no issues but dentist asked if the patient could have developed an allergy to the hema. Informed dentist that it is a possibility. I instructed dentist to have the patient stop using the desensitizer and see if the swelling subsides. Also suggested that the patient rinse and clean her whitening trays well to remove any desensitizer residue. Per follow-up with dental office on 12-9-2017, there is no additional concerns from the patient. This may have then been just a developed allergic reaction to the hema desensitizer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2018-00006 |
| MDR Report Key | 7192568 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-15 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-12-19 |
| Date Mfgr Received | 2017-12-19 |
| Date Added to Maude | 2018-01-15 |
| 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 | 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 | 2018-01-15 |
| 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 | 2018-01-15 |