MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-22 for K?R DESENSITIZER 10-1012 manufactured by Evolve Dental Technologies, Inc..
[139671161]
Likely allergic reaction to the hema in the desensitizer.
Patient Sequence No: 1, Text Type: N, H10
[139671162]
Patient reported via online chat that she had soreness in her tongue and lower lip and was losing her sense of taste. She also reported a small blister forming in her lower lip. Asked her via chat if she was using desensitizer and if it said k? R desensitizer or k? R complete on the bottle. She confirmed that it was k? R desensitizer which is the hema based product. I told her that she may be having an allergic reaction to the hema and to stop using the desensitizer and thoroughly clean her whitening trays. I sent her a replacement with the k? R complete potassium oxalate desensitizer. Followed up with patient on march 12, 2019, patient stated that her mouth is feeling much better and she threw all of the old desensitizers away. She received the new desensitizer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010407924-2019-00004 |
| MDR Report Key | 8446383 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-22 |
| 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 | 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 | 2019-03-22 |
| 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 | 2019-03-22 |