| Brand Name | DONJOY COOL, TROM ADVANCE |
|---|
| 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. |
|
|---|
| Manufacturer Contact |
|
brian
becker
|
| 2900 lake vista drive |
| lewisville, TX 75067
|
|
|---|
| MDR Report Key | 9078980 |
|---|
| MDR Text Key | 162272692 |
|---|
| Report Number | 9616086-2019-00065 |
|---|
| 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 |
09/17/2019 |
|---|
| 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 | 11-9114-9 |
|---|
| Was Device Available for Evaluation? |
No
|
|---|
| Initial Date Manufacturer Received |
08/22/2019
|
|---|
| Initial Date FDA Received | 09/17/2019 |
|---|
| 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 |
|---|
| Patient Outcome(s) |
Required Intervention;
|
|
|
