Brand Name | BABY GORILLA/GORILLA PLATING SYSTEM |
Type of Device | K-WIRE, SINGLE ENDED TROCAR TIP, SMOOTH, 1.6 X 100 MM |
Manufacturer (Section D) |
PARAGON 28, INC |
14445 grasslands dr |
englewood CO 80112 |
|
Manufacturer Contact |
jenny
conger
|
14445 grasslands dr |
englewood, CO 80112
|
7203721212
|
|
MDR Report Key | 14027571 |
MDR Text Key | 290937128 |
Report Number | 3008650117-2022-00033 |
Device Sequence Number | 1 |
Product Code |
HXI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/06/2022 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | P99-192-1610 |
Device Catalogue Number | P99-192-1610 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/08/2022
|
Initial Date FDA Received | 04/06/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
Patient Sex | Male |
Patient Weight | 64 KG |
|
|