Brand Name | JELCO |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
201 west queen st. |
southington CT 06489 |
|
MDR Report Key | 8335181 |
MDR Text Key | 136043288 |
Report Number | 8335181 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 10351688071217 |
UDI-Public | (01)10351688071217 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
01/29/2019,02/01/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/13/2019 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 306701 |
Device Lot Number | 3719639 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/29/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/13/2019 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|