FDA Adverse Event
Malfunction
Summary report: N
SYSTEM B HEAT SOURCE
MDR report key: 3222655
·
Received July 12, 2013
Report
- Report Number
- 2016150-2013-00071
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Report Date
- June 13, 2013
- Manufacturer
- SYBRONENDO
- Product Code
- EAT
- PMA / PMN Number
- K970715
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A VISUAL AND PHYSICAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT A SPRING WAS BENT ON THE DEVICE, CAUSING CONSTANT HEATING.
Additional Manufacturer Narrative · 1
THE DOCTOR CONFIRMED THAT NO MEDICAL ATTENTION OR PRESCRIPTION MEDICATION WAS REQUIRED. THE DOCTOR ICED HIS HAND FOR A BRIEF PERIOD AND THE BURN HEALED ON ITS OWN AFTER A FEW DAYS. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN.
Description of Event or Problem · 1
A DOCTOR ALLEGED THAT THE SYSTEM B HEAT SOURCE DEVICE CONTINUED TO HEAT AFTER BEING UNPLUGGED AND THE DOCTOR HAD BURNED THE INDEX FINGER ON HIS LEFT HAND WHILE ATTEMPTING TO REMOVE THE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324617 | SYSTEM B HEAT SOURCE | PULP TESTER | EAT | SYBRONENDO | 15-1908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |