Brand Name | ITRACK 250A |
Type of Device | OPHTHALMIC MICROCATHETER, MPA, MHX |
Manufacturer (Section D) |
ELLEX ISCIENCE, INC |
4055 campbell avenue |
menlo park CA 94025 |
|
Manufacturer Contact |
lisa
sims
|
4055 campbell avenue |
menlo park, CA 94025
|
6504212757
|
|
MDR Report Key | 4258667 |
MDR Text Key | 5048948 |
Report Number | 3005641545-2014-00003 |
Device Sequence Number | 1 |
Product Code |
MPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K080067 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
08/28/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/03/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2014 |
Device Model Number | ITRACK |
Device Catalogue Number | IT-250A |
Device Lot Number | 1404-03 |
Other Device ID Number | (01)00893872001059 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 08/20/2014 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/12/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/29/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 3005641545-08/11/14-001R |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|