Brand Name | COOK-SWARTZ DOPPLER PROBE |
Type of Device | ITX TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
Manufacturer (Section D) |
COOK VASCULAR INC |
1186 montgomery lane |
vandergrift PA 15690 |
|
Manufacturer Contact |
larry
pool
|
750 daniels way |
bloomington, IN 47404
|
8128294891
|
|
MDR Report Key | 7088265 |
MDR Text Key | 93892324 |
Report Number | 2522007-2017-00047 |
Device Sequence Number | 1 |
Product Code |
ITX
|
UDI-Device Identifier | 00827002213630 |
UDI-Public | (01)00827002213630(17)200731(10)N148387 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K022649 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/06/2017 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | DP-SDP001 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/06/2017 |
Initial Date FDA Received | 12/06/2017 |
Supplement Dates Manufacturer Received | 11/06/2017
|
Supplement Dates FDA Received | 02/07/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/08/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|