Type of Device | SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC |
Manufacturer (Section D) |
BARD ACCESS SYSTEMS |
605 n. 5600 w. |
salt lake city UT 84116 |
|
Manufacturer (Section G) |
DYMAX CORP. |
141 zehner school road |
|
zelienople PA 16063 |
|
Manufacturer Contact |
shelly
gilbert
|
605 n. 5600 w. |
salt lake city, UT 84116
|
8015225640
|
|
MDR Report Key | 9685045 |
MDR Text Key | 193358255 |
Report Number | 3006260740-2020-00467 |
Device Sequence Number | 1 |
Product Code |
IYO
|
UDI-Device Identifier | 00801741124341 |
UDI-Public | (01)00801741124341 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K113808 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 9770131 |
Device Catalogue Number | 9770131 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
01/08/2020 |
Initial Date FDA Received | 02/08/2020 |
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 |
Reuse
|
Patient Sequence Number | 1 |