Brand Name | BAKRI TAMPONADE BALLOON CATHETER |
Type of Device | KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC |
Manufacturer (Section D) |
COOK UROLOGICAL INC. |
spencer IN 47460 |
|
Manufacturer Contact |
rita
harden, director
|
p.o. box 227 |
spencer, IN 47460
|
8123392235
|
|
MDR Report Key | 3779775 |
MDR Text Key | 20291796 |
Report Number | 1820334-2014-00172 |
Device Sequence Number | 1 |
Product Code |
KNA
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K062438 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
03/24/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2017 |
Device Catalogue Number | J-SOS-100500 |
Device Lot Number | U2445550 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 03/20/2014 |
Device Age | 2 MO |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
03/25/2014
|
Initial Date FDA Received | 04/21/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/16/2014 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|