Brand Name | BIS |
Type of Device | ELECTRODE, CUTANEOUS |
Manufacturer (Section D) |
CELESTICA ELECTRONICS S PTE LTD |
no. 6 serangoon north avenue 5 |
singapore 55491 0 |
SG 554910 |
|
Manufacturer (Section G) |
CELESTICA ELECTRONICS S PTE LTD |
no. 6 serangoon north avenue 5 |
|
singapore 55491 0 |
SG
554910
|
|
Manufacturer Contact |
avi
kluger
|
5920 longbow drive |
boulder, CO 80301
|
3035306582
|
|
MDR Report Key | 8608466 |
MDR Text Key | 144998766 |
Report Number | 2936999-2019-00339 |
Device Sequence Number | 1 |
Product Code |
GXY
|
UDI-Device Identifier | 20884521134307 |
UDI-Public | 20884521134307 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K093183 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
05/14/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 186-0106 |
Device Catalogue Number | 186-0106 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/23/2019 |
Initial Date FDA Received | 05/14/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 59 YR |
Patient Weight | 56 |
|
|