Brand Name | TRICUT® STRAIGHT SHAFT 4MM 11CM LONG |
Type of Device | BUR, EAR, NOSE AND THROAT |
Manufacturer (Section D) |
MEDTRONIC XOMED INC. |
6743 southpoint dr n |
jacksonville FL 32216 |
|
Manufacturer (Section G) |
MEDTRONIC XOMED INC. |
6743 southpoint dr n |
|
jacksonville FL 32216 |
|
Manufacturer Contact |
uriza
shums
|
6743 southpoint drive north |
jacksonville, FL 32216
|
9043328405
|
|
MDR Report Key | 7316435 |
MDR Text Key | 101595003 |
Report Number | 1045254-2018-00081 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
UDI-Device Identifier | 20681490047450 |
UDI-Public | 20681490047450 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
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 |
04/10/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1884004 |
Device Catalogue Number | 1884004 |
Device Lot Number | 0214390136 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/08/2018 |
Initial Date FDA Received | 03/06/2018 |
Supplement Dates Manufacturer Received | 03/14/2018
|
Supplement Dates FDA Received | 04/10/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/13/2017 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 41 YR |
|
|