FDA Adverse Event
Malfunction
Summary report: N
RUSCH GREEN RUSCHLITE DISP MTL MILL 2
MDR report key: 3970607
·
Received June 2, 2014
Report
- Report Number
- 1044475-2014-00150
- Event Type
- Malfunction
- Date Received
- June 2, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 15, 2014
- Manufacturer
- TELEFLEX
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE AVAILABLE FOR EVAL? IT IS UNK IF THE DEVICE SAMPLE IS AVAILABLE FOR EVAL.
Description of Event or Problem · 1
THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE PLASTIC WAS BROKEN ON THE BLADE WHEN IT WAS OPENED BY THE CLINICIAN PRIOR TO PT USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320936 | RUSCH GREEN RUSCHLITE DISP MTL MILL 2 | LARYNGOSCOPE BLADE | CCW | TELEFLEX | 1402422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |