Brand Name | PORTEX® SACETT¿ SUCTION ABOVE CUFF ET 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 HEALTHCARE MANUFACTURING S.A. DE C.V. |
a d no.4 |
parque industrial internaciona |
tijuana, bc |
MX
|
|
Manufacturer Contact |
dave
halverson
|
6000 nathan lane north |
minneapolis, MN 55442
|
7633833310
|
|
MDR Report Key | 7234432 |
MDR Text Key | 98830253 |
Report Number | 3012307300-2018-00172 |
Device Sequence Number | 1 |
Product Code |
BTO
|
UDI-Device Identifier | 55019315059542 |
UDI-Public | 55019315059542 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/01/2018 |
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? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 05/21/2022 |
Device Catalogue Number | 100/189/080 |
Device Lot Number | 3406231 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/17/2018 |
Initial Date FDA Received | 02/01/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/27/2017 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|