FDA Adverse Event
Malfunction
Summary report: N
RUSCH EMERALD FO MILLER BLADE 2
MDR report key: 3813222
·
Received March 31, 2014
Report
- Report Number
- 1044475-2014-00107
- Event Type
- Malfunction
- Date Received
- March 31, 2014
- Date of Event
- March 20, 2014
- Report Date
- March 20, 2014
- Manufacturer
- TELEFLEX
- Product Code
- CCW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BLADE IS STICKING ONTO THE HANDLE AND CANNOT CAN BE REMOVED EASILY. THE ALLEGED ISSUE OCCURRED DURING PRE-TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190033 | RUSCH EMERALD FO MILLER BLADE 2 | LARYNGOSCOPE BLADE | CCW | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |