N
Patient 1
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.
MAUDE MDR 8223880
- MDR report key
- 8223880
- Report number
- 3010407924-2018-00014
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-10-15
- Date received
- 2019-01-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. LISA FJASTAD
- Address
- 5 VANDERBILT IRVINE CA 92618 US
- Phone
- 949-949-9497
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | K?R DESENSITIZER | AGENT, TOOTH BONDING, RESIN | EVOLVE DENTAL TECHNOLOGIES, INC. | KLE | 10-1012 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-07 | 0 | 1. L |
Event Narratives#
D
Patient 1
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.