Brand Name | CHATTANOOGA VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL |
Type of Device | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL |
Manufacturer (Section D) |
DJO, LLC |
1430 decision street |
vista CA 92081 |
|
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
22244
|
|
Manufacturer Contact |
brian
becker
|
2900 lake vista drive |
lewisville, TX 75067
|
|
MDR Report Key | 9510522 |
MDR Text Key | 208331572 |
Report Number | 9616086-2019-00085 |
Device Sequence Number | 1 |
Product Code |
GZI
|
UDI-Device Identifier | 00888912292849 |
UDI-Public | 00888912292849 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K031077 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/23/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/23/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 2761 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/15/2019 |
Date Manufacturer Received | 04/11/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
|
|