Brand Name | WAYNE PNEUMOTHORAX TRAY |
Type of Device | DQR CANNULA, CATHETER |
Manufacturer (Section D) |
COOK INC |
750 daniels way |
bloomington IN 47404 |
|
Manufacturer (Section G) |
COOK INC |
750 daniels way |
|
bloomington IN 47404 |
|
Manufacturer Contact |
larry
pool
|
750 daniels way |
bloomington, IN 47404
|
8128294891
|
|
MDR Report Key | 8175593 |
MDR Text Key | 131143029 |
Report Number | 1820334-2018-03812 |
Device Sequence Number | 1 |
Product Code |
DQR
|
UDI-Device Identifier | 00827002120327 |
UDI-Public | (01)00827002120327(17)160501(10)5061408 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/18/2018 |
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 Expiration Date | 05/01/2016 |
Device Catalogue Number | C-UTPTY-1400-WAYNE-112497 |
Device Lot Number | 5061408 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/29/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/14/2018 |
Initial Date FDA Received | 12/18/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/01/2014 |
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 |