Brand Name | SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR |
Type of Device | SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC |
Manufacturer (Section D) |
C.R. BARD, INC. (BASD) -3006260740 |
605 north 5600 west |
salt lake city 84116 |
|
Manufacturer (Section G) |
DYMAX CORP. -2523003 |
110 marshall drive |
|
warrendale PA 15086 |
|
Manufacturer Contact |
becky
garcia
|
605 north 5600 west |
salt lake city 84116
|
8015950700
|
|
MDR Report Key | 14570819 |
MDR Text Key | 293140888 |
Report Number | 3006260740-2022-02039 |
Device Sequence Number | 1 |
Product Code |
IYO
|
UDI-Device Identifier | 00801741138263 |
UDI-Public | (01)00801741138263 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K182281 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Notification |
Type of Report
| Initial |
Report Date |
05/16/2022 |
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 | 9770600 |
Device Catalogue Number | 9770600 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/13/2022 |
Initial Date FDA Received | 06/01/2022 |
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
|
Removal/Correction Number | 2243072-10/11/2019-013-C |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|