Brand Name | SLALOM PTA .018 HP 40 3X4 |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
CORDIS CASHEL |
cahir road |
cashel, co. |
tipperary |
EI
|
|
Manufacturer (Section G) |
CORDIS CASHEL |
cahir road |
cashel, co. |
tipperary |
EI
|
|
Manufacturer Contact |
karla
castro
|
14201 nw 60th ave |
miami lakes, FL 33014
|
7863138372
|
|
MDR Report Key | 9115424 |
MDR Text Key | 160044116 |
Report Number | 9616099-2019-03222 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K003159 |
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 |
Report Date |
10/17/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 09/25/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Expiration Date | 09/30/2020 |
Device Catalogue Number | 4393040T |
Device Lot Number | 17728332 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/11/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 10/14/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/25/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|