Brand Name | SABER RX2MM4CM155 |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
CORDIS DE MEXICO |
circuito int nte 1820 |
juarez 32575 |
MX
32575
|
|
Manufacturer (Section G) |
CORDIS DE MEXICO |
circuito int nte 1820 |
|
juarez 32575 |
MX
32575
|
|
Manufacturer Contact |
karla
castro
|
14201 nw 60th ave |
miami lakes, FL 33014
|
7863138372
|
|
MDR Report Key | 9535447 |
MDR Text Key | 200249816 |
Report Number | 9616099-2019-03445 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (Y/N) | N |
Reporter Country Code | JA |
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,Followup,Followup |
Report Date |
02/11/2020 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 12/31/2019 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device EXPIRATION Date | 03/31/2020 |
Device MODEL Number | 51002004L |
Device Catalogue Number | 51002004L |
Device LOT Number | 17661083 |
Was Device Available For Evaluation? |
Yes
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 02/06/2020 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 04/04/2017 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|