Brand Name | CHATTANOOGA DURA-STICK PREM 5CM SQUARE 4/PK |
Type of Device | ELECTRODE, CUTANEOUS |
Manufacturer (Section D) |
DJO, LLC |
1430 decision street |
vista CA 92081 9663 |
|
Manufacturer (Section G) |
DJO TUNISIE |
zone industrielle poudriere 1 |
aout |
sfax 3002 |
TS
3002
|
|
Manufacturer Contact |
brian
becker
|
2900 lake vista drive |
lewisville, TX 75067
|
|
MDR Report Key | 8909883 |
MDR Text Key | 154903439 |
Report Number | 3007615436-2019-00003 |
Device Sequence Number | 1 |
Product Code |
GXY
|
UDI-Device Identifier | 00888912341073 |
UDI-Public | (01)00888912341073(17)210228(10)AM000050265 |
Combination Product (y/n) | N |
PMA/PMN Number | K874469 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,foreign |
Type of Report
| Initial |
Report Date |
08/19/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/20/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Expiration Date | 02/28/2021 |
Device Model Number | 42209 |
Device Lot Number | AM000050265 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 07/24/2019 |
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;
|
|
|