Brand Name | GREEN RUSCHLITE DISP MTL MILL 2 |
Type of Device | LARYNGOSCOPE BLADE |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
2917 weck dr. |
|
research triangle park NC 27709 |
|
Manufacturer Contact |
warrenda
peterson
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9193613959
|
|
MDR Report Key | 4552848 |
MDR Text Key | 5460076 |
Report Number | 1044475-2015-00108 |
Device Sequence Number | 1 |
Product Code |
CCW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/30/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 004550002 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/30/2015
|
Initial Date FDA Received | 02/25/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |