FDA Adverse Event
Injury
Summary report: N
NX3 DUAL CURE CLEAR
MDR report key: 1891239
·
Received November 4, 2010
Report
- Report Number
- 2024312-2010-00096
- Event Type
- Injury
- Date Received
- November 4, 2010
- Report Date
- October 4, 2010
- Manufacturer
- KERR CORPORATION
- Product Code
- EMA
- PMA / PMN Number
- K062519
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DOCTOR REPORTED THAT A VENEER THAT HAD BEEN CEMENTED WITH NX3 DE-BONDED AND WAS SWALLOWED BY THE PATIENT. THE DOCTOR WAS UNWILLING TO PROVIDE FURTHER DETAILS ON THE PROCEDURES THAT WERE USED OR ON THE PATIENT'S CURRENT CONDITION. THE DOCTOR DID NOT RETURN THE PRODUCT, NOR DID SHE PROVIDE THE LOT NUMBER OF THE PRODUCT; THEREFORE NO EVALUATION OR FURTHER INVESTIGATION COULD BE CONDUCTED AND THE CAUSE OF THE DE-BOND REMAINS INCONCLUSIVE.
Description of Event or Problem · 1
ON (B)(6), 2010, A DOCTOR REPORTED THAT A VENEER THAT HAD BEEN PLACED WITH NX3 DUAL CURE CEMENT DE-BONDED AND WAS SWALLOWED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NX3 DUAL CURE CLEAR | DENTAL CEMENT | EMA | KERR CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |