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 |
uriza
shums
|
6743 southpoint drive north |
jacksonville, FL 32216
|
9043328405
|
|
MDR Report Key | 7298522 |
MDR Text Key | 101025851 |
Report Number | 3004209178-2018-04017 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
UDI-Device Identifier | 20681490047481 |
UDI-Public | 20681490047481 |
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/28/2018 |
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 Model Number | 1884008 |
Device Catalogue Number | 1884008 |
Device Lot Number | HG1SQRR |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/02/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/31/2018
|
Initial Date FDA Received | 02/26/2018 |
Supplement Dates Manufacturer Received | 03/05/2018
|
Supplement Dates FDA Received | 03/28/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/12/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|