Brand Name | KANGAROO EPUMP - NEW |
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
|
|
MDR Report Key | 8181665 |
MDR Text Key | 130976777 |
Report Number | 1282497-2018-08209 |
Device Sequence Number | 1 |
Product Code |
LZH
|
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 |
12/19/2018 |
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 | 382400 |
Device Catalogue Number | 382400 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
12/12/2018 |
Initial Date FDA Received | 12/19/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|