Brand Name | PORTEX® BLUE LINE CLASSIC® |
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 INTERNATIONAL LTD. |
boundary road |
|
hythe, kent CT21 6JL |
UK
CT21 6JL
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7660554 |
MDR Text Key | 113149503 |
Report Number | 3012307300-2018-02527 |
Device Sequence Number | 1 |
Product Code |
BTO
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/03/2018 |
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 |
No Information
|
Device Catalogue Number | 100/515/075 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/08/2018 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/05/2018
|
Initial Date FDA Received | 07/03/2018 |
Supplement Dates Manufacturer Received | 06/05/2018
|
Supplement Dates FDA Received | 10/03/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Disability;
|