Brand Name | NIMBUS II PAINPRO AMBULATORY INFUSION PUMP |
Type of Device | AMBULATORY INFUSION PUMP |
Manufacturer (Section D) |
INFUTRONIX, LLC |
177 pine street |
natick MA 01760 |
|
Manufacturer (Section G) |
INFUTRONIX, LLC |
177 pine street |
|
natick MA 01760 |
|
Manufacturer Contact |
frederick
lee
|
177 pine street |
natick, MA 01760
|
5086502007
|
|
MDR Report Key | 18679829 |
MDR Text Key | 335089938 |
Report Number | 3011581908-2024-00143 |
Device Sequence Number | 1 |
Product Code |
FRN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153193 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/09/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | NIMBUS II PAINPRO |
Device Catalogue Number | NIMBUS II PAINPRO |
Device Lot Number | 2202064320 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/07/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/06/2022 |
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 |
|
|