Brand Name | KANGAROO |
Type of Device | PUMP, INFUSION, ENTERAL |
Manufacturer (Section D) |
COVIDIEN |
15 hampshire st |
mansfield MA 02048 |
|
Manufacturer (Section G) |
COVIDIEN |
15 hampshire street |
|
mansfield MA 02048 |
|
Manufacturer Contact |
edward
almeida
|
15 hampshire street |
mansfield, MA 02048
|
5084524151
|
|
MDR Report Key | 7925480 |
MDR Text Key | 122314485 |
Report Number | 1282497-2018-08086 |
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,Followup |
Report Date |
02/08/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
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
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/05/2018 |
Initial Date FDA Received | 10/02/2018 |
Supplement Dates Manufacturer Received | 09/05/2018
|
Supplement Dates FDA Received | 02/08/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|