Brand Name | SITE~RITE 8 ULTRASOUND SYSTEM 20 MM CUE LINEAR |
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 |
|
MDR Report Key | 11027345 |
MDR Text Key | 222761590 |
Report Number | 3006260740-2020-20981 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | N |
PMA/PMN Number | K182281 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Type of Report
| Initial,Followup |
Report Date |
03/10/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/17/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 9770603 |
Device Catalogue Number | 9770603 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/19/2021 |
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 03/10/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Treatment Data |
Date Received: 12/17/2020 Patient Sequence Number: 1 |
|
|