Brand Name | TRICUT® STRAIGHT SHAFT 4MM 13CM LONG M4 ROTATABLE |
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 | 8175365 |
MDR Text Key | 130699817 |
Report Number | 3004209178-2018-27926 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
UDI-Device Identifier | 00613994233325 |
UDI-Public | 00613994233325 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/18/2018 |
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 | 04/13/2022 |
Device Model Number | 1884080HR |
Device Catalogue Number | 1884080HR |
Device Lot Number | HG2G64Z |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/23/2018 |
Initial Date FDA Received | 12/18/2018 |
Date Device Manufactured | 04/13/2018 |
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 |