Type of Device | PLATE |
Manufacturer (Section D) |
PARAGON 28, INC. |
14445 grasslands dr. |
englewood CO 80112 |
|
Manufacturer Contact |
victoria
akinboboye
|
14445 grasslands dr. |
englewood, CO 80112
|
7207165439
|
|
MDR Report Key | 16616019 |
MDR Text Key | 312008629 |
Report Number | 3008650117-2023-00062 |
Device Sequence Number | 1 |
Product Code |
HRS
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/24/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/24/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/23/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|