Brand Name | SITE-RITE 8 ULTRASOUND |
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 | 11180947 |
MDR Text Key | 258784998 |
Report Number | 3006260740-2020-21353 |
Device Sequence Number | 1 |
Product Code |
IYO
|
UDI-Device Identifier | 00801741096891 |
UDI-Public | (01)00801741096891 |
Combination Product (y/n) | N |
PMA/PMN Number | K152554 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other,user facility |
Remedial Action |
Notification |
Type of Report
| Initial |
Report Date |
12/23/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/15/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 9770500 |
Device Catalogue Number | 9770500 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/05/2021 |
Date Manufacturer Received | 12/21/2020 |
Was Device Evaluated by Manufacturer? |
No
|
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;
|
|
|