Brand Name | PROTEGE EVERFLX |
Type of Device | STENT, SUPERFICIAL FEMORAL ARTERY |
Manufacturer (Section D) |
COVIDIEN |
4600 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
COVIDIEN |
4600 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
stephanie
riley
|
4600 nathan lane n |
plymouth, MN 55442
|
7633987000
|
|
MDR Report Key | 4297360 |
MDR Text Key | 5052415 |
Report Number | 2183870-2014-00309 |
Device Sequence Number | 1 |
Product Code |
NIP
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P110023 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative,company representati |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/07/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/04/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/17/2016 |
Device Model Number | PRB35-06040120V05 |
Device Catalogue Number | PRB35-06040120V05 |
Device Lot Number | 9803882 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 11/07/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/18/2013 |
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;
|
Patient Age | 63 YR |
|
|