Brand Name | XPS® BUR |
Type of Device | BUR, EAR, NOSE AND THROAT |
Manufacturer (Section D) |
MEDTRONIC XOMED, INC. |
6743 southpoint drive north |
jacksonville FL 32216 |
|
Manufacturer (Section G) |
MEDTRONIC XOMED, INC. |
6743 southpoint drive north |
|
jacksonville FL 32216 |
|
Manufacturer Contact |
uriza
shums
|
6743 southpoint drive north |
jacksonville, FL 32216
|
9043328405
|
|
MDR Report Key | 5335734 |
MDR Text Key | 35207810 |
Report Number | 1045254-2015-00441 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
Combination Product (y/n) | N |
Reporter Country Code | EC |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/09/2015 |
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 |
Health Professional
|
Device Model Number | 1883212HS |
Device Catalogue Number | 1883212HS |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/09/2015 |
Initial Date FDA Received | 12/30/2015 |
Supplement Dates Manufacturer Received | 12/09/2015
|
Supplement Dates FDA Received | 09/19/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|