Brand Name | EPUMP 1000ML SAFETY SCREW SPIK |
Type of Device | PUMP, INFUSION, ENTERAL |
Manufacturer (Section D) |
COVIDIEN |
15 hampshire street |
mansfield MA 02048 |
|
Manufacturer (Section G) |
COVIDIEN |
15 hampshire street |
|
mansfield MA 02048 |
|
Manufacturer Contact |
jill
saraiva
|
15 hampshire street |
mansfield, MA 02048
|
5086183640
|
|
MDR Report Key | 9527734 |
MDR Text Key | 173035646 |
Report Number | 1282497-2019-08844 |
Device Sequence Number | 1 |
Product Code |
LZH
|
UDI-Device Identifier | 10884521155817 |
UDI-Public | 10884521155817 |
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,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/27/2019 |
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 |
No Information
|
Device Model Number | 775100 |
Device Catalogue Number | 775100 |
Initial Date Manufacturer Received |
12/11/2019 |
Initial Date FDA Received | 12/27/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|