Brand Name | XPS® BLADE |
Type of Device | BUR, EAR, NOSE AND THROAT |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
road 31, km. 24, hm 4 |
ceiba norte industrial park |
juncos PR 00777 |
|
Manufacturer Contact |
angie
demo
|
6743 southpoint drive north |
jacksonville, FL 32216
|
9043328355
|
|
MDR Report Key | 7268308 |
MDR Text Key | 100250105 |
Report Number | 3004209178-2018-03246 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Type of Report
| Initial |
Report Date |
02/13/2018 |
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 Expiration Date | 08/11/2021 |
Device Model Number | 1884002HRE |
Device Catalogue Number | 1884002HRE |
Device Lot Number | HG205H5 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/18/2018
|
Initial Date FDA Received | 02/13/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/11/2017 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|