Brand Name | TRICUT® STRAIGHT SHAFT 4MM 11CM LONG |
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 |
christy
cain
|
6743 southpoint drive north |
jacksonville, FL 32216
|
9043328353
|
|
MDR Report Key | 8664484 |
MDR Text Key | 146856219 |
Report Number | 3004209178-2019-10760 |
Device Sequence Number | 1 |
Product Code |
EQJ
|
UDI-Device Identifier | 00681490047456 |
UDI-Public | 00681490047456 |
Combination Product (y/n) | N |
Reporter Country Code | CO |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
07/25/2019 |
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 | 1884004 |
Device Catalogue Number | 1884004 |
Device Lot Number | HG2P0GF |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/03/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/09/2019 |
Initial Date FDA Received | 06/03/2019 |
Supplement Dates Manufacturer Received | 07/05/2019
|
Supplement Dates FDA Received | 07/25/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/17/2018 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |
Patient Weight | 72 |
|
|