Brand Name | DONJOY |
Type of Device | ADJUSTER 3, LATERAL, LT, L |
Manufacturer (Section D) |
DJO, LLC |
1460 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, mx |
|
Manufacturer Contact |
william
fisher
|
1460 decision street |
vista, CA 92081-9663
|
|
MDR Report Key | 7689998 |
MDR Text Key | 114043865 |
Report Number | 9616086-2018-00016 |
Device Sequence Number | 1 |
Product Code |
ITQ
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/16/2018 |
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 | 11-1593-4 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 07/16/2018 |
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 |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|