Brand Name | OMNIPOD INSULIN MANAGEMENT SYSTEM |
Type of Device | PUMP, INFUSION, INSULIN |
Manufacturer (Section D) |
INSULET CORPORATION |
100 nagog park |
acton MA 01720 |
|
Manufacturer (Section G) |
INSULET CORPORATION |
100 nagog park |
|
acton MA 01720 |
|
Manufacturer Contact |
thom
mcnamara
|
100 nagog park |
acton, MA 01720
|
9786007000
|
|
MDR Report Key | 16794085 |
MDR Text Key | 313802049 |
Report Number | 3004464228-2023-10347 |
Device Sequence Number | 1 |
Product Code |
LZG
|
UDI-Device Identifier | 20385081120033 |
UDI-Public | (01)20385081120033 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K211575 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/19/2023 |
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 |
Lay User/Patient
|
Device Model Number | 19191 |
Device Catalogue Number | ZXP425 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/19/2023 |
Initial Date FDA Received | 04/24/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|