Brand Name | AERO® |
Type of Device | PROSTHESIS, TRACHEAL, EXPANDABLE |
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 |
bryson
heaton
|
1600 merit parkway |
south jordan, UT 84095
|
8012084662
|
|
MDR Report Key | 13636442 |
MDR Text Key | 288394986 |
Report Number | 3010665433-2022-00018 |
Device Sequence Number | 1 |
Product Code |
JCT
|
UDI-Device Identifier | 00884450030813 |
UDI-Public | 00884450030813 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K082284 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
02/18/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/01/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 00884450030813 |
Device Catalogue Number | 90129-201/C |
Device Lot Number | E1706347 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/23/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/26/2019 |
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;
|
|
|