Brand Name | NI |
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 | 18991066 |
MDR Text Key | 338790738 |
Report Number | 3011581906-2024-00265 |
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,User Facility,Company Representative,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/28/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/28/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/19/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|