FDA Adverse Event
Malfunction
Summary report: N
SYBRONENDO
MDR report key: 7813184
·
Received August 24, 2018
Report
- Report Number
- 2016150-2018-00051
- Event Type
- Malfunction
- Date Received
- August 24, 2018
- Date of Event
- May 22, 2018
- Report Date
- August 24, 2018
- Manufacturer
- SYBRONENDO
- Product Code
- EKZ
- PMA / PMN Number
- K031664
- Removal / Correction Number
- Z-0413-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO WEIGHT, ETHNICITY, AND RACE. THE PRODUCT HAS BEEN IDENTIFIED AS A POTENTIAL AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE NO FURTHER EVALUATION IS NECESSARY.
Description of Event or Problem · 1
A COMPLAINANT ALLEGED THAT A PATIENT'S LIP WAS BURNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 656330 | SYBRONENDO | ELEMENTS OBTURATION UNIT | EKZ | SYBRONENDO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |