Brand Name | TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE WITH EM TRACKING |
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 |
christy
cain
|
6743 southpoint drive north |
jacksonville, FL 32216
|
9043328353
|
|
MDR Report Key | 8037033 |
MDR Text Key | 126069037 |
Report Number | 1045254-2018-00556 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130608 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/08/2019 |
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 | 1884080EM |
Device Catalogue Number | 1884080EM |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/17/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/08/2018 |
Initial Date FDA Received | 11/05/2018 |
Supplement Dates Manufacturer Received | 01/04/2019 04/10/2019
|
Supplement Dates FDA Received | 01/31/2019 05/08/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 | 42 YR |
Patient Weight | 116 |