Brand Name | COOL, X-ACT ROM LITE, POST OP |
Type of Device | JOINT, KNEE, EXTERNAL BRACE |
Manufacturer (Section D) |
DJO, LLC |
1430 decision street |
vista CA 92081 9663 |
|
Manufacturer (Section G) |
DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
carretera libre tijuana tecate |
20230 submetropoli el florido |
tijuana, b.c. 22244, |
MX
|
|
Manufacturer Contact |
brian
becker
|
2900 lake vista drive |
lewisville, TX 75067
|
|
MDR Report Key | 8491129 |
MDR Text Key | 141184471 |
Report Number | 9616086-2019-00017 |
Device Sequence Number | 1 |
Product Code |
ITQ
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other,user facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/08/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 11-2161-9 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/14/2019
|
Initial Date FDA Received | 04/08/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|