Brand Name | 3.5FR URETHANE UMB CATH |
Type of Device | UMBILICAL VESSEL CATHETER |
Manufacturer (Section D) |
COVIDIEN |
covidien manufacturing solutions sa |
edificio 820 calle #2 zona france coyol |
alajuela |
CS |
|
Manufacturer (Section G) |
COVIDIEN |
covidien manufacturing solutions sa |
edificio 820 calle #2 zona france coyol |
alajuela |
CS
|
|
Manufacturer Contact |
edward
almeida
|
15 hampshire st |
mansfield, MA 02048
|
5084524151
|
|
MDR Report Key | 6160093 |
MDR Text Key | 62382710 |
Report Number | 3009211636-2016-00497 |
Device Sequence Number | 1 |
Product Code |
FOS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/18/2016 |
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 Model Number | 8888160333 |
Device Catalogue Number | 8888160333 |
Device Lot Number | 1619500140 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/18/2016 |
Initial Date FDA Received | 12/09/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |