FDA Adverse Event
Malfunction
Summary report: N
LARYNGOSCOPE HANDLE
MDR report key: 3010450
·
Received March 14, 2013
Report
- Report Number
- 3010450
- Event Type
- Malfunction
- Date Received
- March 14, 2013
- Date of Event
- February 4, 2013
- Report Date
- March 14, 2013
- Manufacturer
- NEWMATIC MEDICAL
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
THE BATTERY CAP THREADS FOR THE LARYNGOSCOPE KEEPS STRIPPING AND THE CAP WILL FALL OFF. THIS LETS THE BATTERIES FALL OUT AND THEY CAN BE DRAWN TO THE MAGNET.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MRI STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 108507 | LARYNGOSCOPE HANDLE | LARYGNOSCOPE, HANDLE | CCW | NEWMATIC MEDICAL | NONE | 2812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |