Brand Name | PORTEX® BLUE LINE ULTRA® SOFT SEAL® TRACHEOSTOMY TUBE |
Type of Device | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
Manufacturer (Section G) |
SMITHS MEDICAL CZECH REPUBLIC A. S. |
olomoucká 306 |
hranice 1 - mesto |
hranice, 753 0 1 |
EZ
753 01
|
|
Manufacturer Contact |
lisa
perz
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833074
|
|
MDR Report Key | 6238472 |
MDR Text Key | 64391167 |
Report Number | 3012307300-2017-00068 |
Device Sequence Number | 1 |
Product Code |
BTO
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/15/2016 |
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? |
Yes
|
Device Operator |
Patient Family Member or Friend
|
Device Catalogue Number | 100/810/090CZ |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/15/2016 |
Initial Date FDA Received | 01/10/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|