D
Patient 1
THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE LIGHT ON THE BLADE IS NOT WORKING. THE ISSUE WAS DETECTED PRIOR TO USE.
MAUDE MDR 3851607
- MDR report key
- 3851607
- Report number
- 1044475-2014-00070
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-02-26
- Date received
- 2014-03-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MARGIE BURTON, RN, REG AFFAIRS
- Address
- P.O. BOX 12600 RTP NC 27709 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-03-25 | 0 |
Event Narratives#
N
Patient 1
THE DEVICE SAMPLE WAS RECEIVED BY THE MFR, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.