Brand Name | LC PCA HOSPIRA MEDNE |
Type of Device | 80MEA |
Manufacturer (Section D) |
HOSPIRA COSTA RICA LTD. |
zona franca global |
la aurora heredia |
CS |
|
Manufacturer (Section G) |
HOSPIRA COSTA RICA LTD. |
zona franca global |
|
la aurora heredia |
CS
|
|
Manufacturer Contact |
juergen
schmider, md, vp
|
275 n field dr |
bldg no. h2-1e, dept no. 097u |
lake forest, IL 60045
|
2242125740
|
|
MDR Report Key | 3802066 |
MDR Text Key | 4521853 |
Report Number | 9615050-2014-00867 |
Device Sequence Number | 1 |
Product Code |
MEA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042800 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Not Applicable
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
12/16/2013 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 20709 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 01/03/2014 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/13/2014
|
Initial Date FDA Received | 02/04/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/01/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | FA301-02 |
Patient Sequence Number | 1 |
|
|