MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-07 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[132294189]
Likely allergic reaction to the hema in the desensitizer. Note: this mdr is submitted late due to an expired public key, which needed renewal for submission.
Patient Sequence No: 1, Text Type: N, H10
[132294190]
The patient called, stating that she began whitening at home and when she woke up the next day, her lips, gums, and cheeks were swollen. The patient simply stopped whitening for a week before starting up again, utilizing a desensitizer as well. Again, the patient woke up to swollen lips, gums, and cheeks, at which point she called evolve dental. Advised the patient to discontinue using the desensitizer permanently, and if/when she does decide to resume whitening, she needs to make sure to clean her trays very thoroughly with cold water, at which point she could resume whitening again (once she's fully healed and all swelling is gone). We are shipping out one bottle of k? R complete desensitizer to replace the bottle the patient began to utilize. Were able to reach the dental office on (b)(6) 2018 and spoke with (b)(6) who confirmed that the patient was using the old k? R desensitizer, containing hema. Advised office to notify patient to discontinue use of the desensitizer "indefinetel", as she may be allergic to the hema in the desensitizer. Dental office reported that patient has resumed whitening without utilizing any desensitizer at all and she has had no further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2018-00014 |
| MDR Report Key | 8223880 |
| Report Source | CONSUMER |
| Date Received | 2019-01-07 |
| Date of Report | 2018-11-12 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-11-12 |
| Date Added to Maude | 2019-01-07 |
| 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 | 2019-01-07 |
| 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 | 2019-01-07 |