Brand Name | PROMETRA II PROGRAMMABLE PUMP |
Type of Device | IMPLANTABLE INFUSION PUMP |
Manufacturer (Section D) |
FLOWONIX MEDICAL, INC. |
500 international drive |
suite 200 |
mount olive NJ 07828 |
|
Manufacturer Contact |
karen
matis
|
500 international drive |
suite 200 |
mount olive, NJ 07828
|
9734269229
|
|
MDR Report Key | 7345830 |
MDR Text Key | 102709366 |
Report Number | 3010079947-2018-00050 |
Device Sequence Number | 1 |
Product Code |
LKK
|
UDI-Device Identifier | 00810335020228 |
UDI-Public | 0100810335020228102382117180619 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P080012 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/16/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 06/19/2018 |
Device Model Number | 13827 |
Device Catalogue Number | 13827 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/16/2018 |
Initial Date FDA Received | 03/16/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/19/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|