Brand Name | TREK RX |
Type of Device | CORONARY DILATATION CATHETER |
Manufacturer (Section D) |
ABBOTT VASCULAR |
26531 ynez rd. |
temecula CA 92591 4628 |
|
Manufacturer (Section G) |
ABBOTT VASCULAR COSTA RICA, REG # 3009564766 |
52 calle 3 b31 coyol free zone |
|
el coyol alajuela |
CS
|
|
Manufacturer Contact |
lindsey
bell
|
26531 ynez rd. |
temecula, CA 92591-4628
|
9519143996
|
|
MDR Report Key | 10038931 |
MDR Text Key | 191843895 |
Report Number | 2024168-2020-04187 |
Device Sequence Number | 1 |
Product Code |
LOX
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K103110 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/16/2020 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 05/08/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 05/31/2021 |
Device Catalogue Number | 1012268-12 |
Device Lot Number | 80615G1 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 09/21/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/15/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|