FDA Adverse Event
Malfunction
Summary report: N
SYBRONENDO
MDR report key: 7996301
·
Received October 23, 2018
Report
- Report Number
- 2016150-2018-00044
- Event Type
- Malfunction
- Date Received
- October 23, 2018
- Report Date
- June 21, 2018
- Manufacturer
- SYBRONENDO
- Product Code
- EKR
- PMA / PMN Number
- K031664
- Removal / Correction Number
- Z-0413-2018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO WEIGHT, ETHNICITY, AND RACE. DATE OF EVENT WAS NOT PROVIDED. NO INFORMATION WAS PROVIDED IN REGARDS TO THE SERIAL NUMBER, THEREFORE DEVICE MANUFACTURING DATE COULD NOT BE DETERMINED. THIS WILL BE TWENTY-THREE (23) OF TWENTY-FOUR (24) MEDICAL DEVICE REPORTS THAT WILL BE SUBMITTED. THE PRODUCT HAS BEEN IDENTIFIED AS AN AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE NO FURTHER EVALUATION IS NECESSARY.
Description of Event or Problem · 1
AN ALLEGED COMPLAINT WAS REPORTED THAT MULTIPLE PATIENTS SUFFERED A TOUGHER POST-OPERATIVE RECOVERY. THEY FELT A VERY HIGH SENSITIVITY DUE TO HIGHER HEAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834470 | SYBRONENDO | FINE BUCHANAN PLUGGER | EKR | SYBRONENDO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |