Brand Name | BABY GORILLA/GORILLA PLATING SYSTEM |
Type of Device | ANTERIOR TT PLATE, STANDARD, FLAT, RIGHT, 08-HOLE |
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 | 15795275 |
MDR Text Key | 303630733 |
Report Number | 3008650117-2022-00132 |
Device Sequence Number | 1 |
Product Code |
HRS
|
Combination Product (y/n) | N |
Reporter Country Code | NO |
PMA/PMN Number | K190365 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/08/2022 |
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 | P53-401-R201 |
Device Catalogue Number | P53-401-R201 |
Device Lot Number | WV2009755 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Initial Date Manufacturer Received |
11/01/2022 |
Initial Date FDA Received | 11/14/2022 |
Supplement Dates Manufacturer Received | 11/01/2022
|
Supplement Dates FDA Received | 12/08/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 Age | 70 YR |
Patient Sex | Female |
Patient Weight | 80 KG |
|
|