Brand Name | AERO TRACHEOBRONCHIAL STENT |
Type of Device | TRACHEOBRONCHIAL STENT |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
14646 kirby drive |
houston TX 77047 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC. |
14646 kirby drive |
|
houston TX 77047 |
|
Manufacturer Contact |
david
lockridge
|
1600 merit parkway |
south jordan, UT 84095
|
8012084551
|
|
MDR Report Key | 9469404 |
MDR Text Key | 185591240 |
Report Number | 3010665433-2019-00084 |
Device Sequence Number | 1 |
Product Code |
JCT
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K082284 |
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 |
11/18/2019 |
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 Expiration Date | 07/31/2023 |
Device Catalogue Number | 90129-201/JPC |
Device Lot Number | E1403811 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/18/2019 |
Initial Date FDA Received | 12/13/2019 |
Supplement Dates Manufacturer Received | 01/03/2020
|
Supplement Dates FDA Received | 01/10/2020
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/07/2018 |
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) |
Hospitalization;
Required Intervention;
|