Brand Name | KANGAROO JOEY, PUMP W/ POLE CLMP |
Type of Device | FEEDING PUMP |
Manufacturer (Section D) |
JABIL SINGAPORE |
16 tampines industrial crescent |
singapore 0000 |
SG 0000 |
|
Manufacturer (Section G) |
JABIL SINGAPORE |
16 tampines industrial crecsent |
|
singapore |
SN
|
|
Manufacturer Contact |
elaine
bishop
|
15 hampshire street |
mansfield, MA 02048
|
5084524686
|
|
MDR Report Key | 4041004 |
MDR Text Key | 17280660 |
Report Number | 3009247326-2014-00015 |
Device Sequence Number | 1 |
Product Code |
LZH
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial,Followup |
Report Date |
07/24/2014 |
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 |
Other
|
Device Model Number | 383400 |
Device Catalogue Number | 383400 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
09/30/2014 |
Initial Date FDA Received | 08/05/2014 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/30/2014
|
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 |
|
|