Brand Name | KANGAROO |
Type of Device | PUMP, INFUSION, ENTERAL |
Manufacturer (Section D) |
COVIDIEN |
2824 airwest blvd |
plainfield IN 46168 |
|
Manufacturer (Section G) |
COVIDIEN |
2824 airwest blvd |
|
plainfield IN 46168 |
|
Manufacturer Contact |
edward
almeida
|
15 hampshire street |
mansfield, MA 02048
|
5084524151
|
|
MDR Report Key | 7756936 |
MDR Text Key | 116242910 |
Report Number | 3008361498-2018-00405 |
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,Followup |
Report Date |
10/12/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/07/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 382400 |
Device Catalogue Number | 382400 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/20/2018 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/08/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|