Brand Name | JELCO |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan ln n |
minneapolis MN 55442 |
|
MDR Report Key | 13677694 |
MDR Text Key | 286646977 |
Report Number | 13677694 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 10351688071187 |
UDI-Public | (01)10351688071187 |
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 |
02/22/2022 |
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 | 306001 |
Device Lot Number | 4231923 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/22/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/07/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/07/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 29930 DA |
Patient Sex | Male |
|
|