Brand Name | SITE~RITE 8 ULTRASOUND SYSTEM |
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 | 14465388 |
MDR Text Key | 292364599 |
Report Number | 3006260740-2022-01906 |
Device Sequence Number | 1 |
Product Code |
IYO
|
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | K152554 |
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 |
05/05/2022 |
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 Catalogue Number | 9770550 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/01/2022
|
Initial Date FDA Received | 05/21/2022 |
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
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|