Brand Name | RUSCH GREENSPEC FO HANDLE MED. |
Type of Device | LARYNGOSCOPE HANDLE |
Manufacturer (Section D) |
TELEFLEX |
research triangle park NC 27709 |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
2917 weck dr. |
|
|
|
Manufacturer Contact |
margie
burton, rn
|
po box 12600 |
rtp, NC 27709
|
9194334965
|
|
MDR Report Key | 4094949 |
MDR Text Key | 18029404 |
Report Number | 1044475-2014-00264 |
Device Sequence Number | 1 |
Product Code |
GCI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
08/14/2014 |
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 |
Health Professional
|
Device Catalogue Number | 004411100 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/14/2014
|
Initial Date FDA Received | 09/02/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |