Brand Name | DONJOY ARMOR, ACL, STD, RT, L |
Type of Device | JOINT, KNEE, EXTERNAL BRACE |
Manufacturer (Section G) |
DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V. |
carretera libre tijuana tecate |
20230 submetropoli el florido |
tijuana, b.c., mx 22244 |
MX
22244
|
|
Manufacturer Contact |
christine
bonczyk
|
2900 lake vista drive |
lewisville, ca
|
|
MDR Report Key | 9981348 |
MDR Text Key | 192151270 |
Report Number | 9616086-2020-00013 |
Device Sequence Number | 1 |
Product Code |
ITQ
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Type of Report
| Initial |
Report Date |
04/20/2020 |
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 | 11-1444-4 |
Initial Date Manufacturer Received |
04/08/2020 |
Initial Date FDA Received | 04/21/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|