Brand Name | CHATTANOOGA INTELECT LEGEND XT COMBOUS STD |
Type of Device | STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT |
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., mx 22244 |
MX
22244
|
|
Manufacturer Contact |
christine
bonczyk
|
2900 lake vista drive |
lewisville, TX 75067
|
|
MDR Report Key | 11634000 |
MDR Text Key | 258657217 |
Report Number | 9616086-2020-00031 |
Device Sequence Number | 1 |
Product Code |
IMG
|
UDI-Device Identifier | 00888912292740 |
UDI-Public | 00888912292740 |
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 |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/08/2021 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 2760 |
Initial Date Manufacturer Received |
08/18/2020 |
Initial Date FDA Received | 04/08/2021 |
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) |
Other;
|
|
|