Brand Name | PORTEX TRACHEOSTOMY TUBE |
Type of Device | TRACHEOSTOMY TUBE |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
5700 west 23rd avenue |
gary IN 46406 |
|
Manufacturer (Section G) |
SMITHS MEDICAL ASD, INC. |
5700 west 23rd avenue |
|
gary IN 46406 |
|
Manufacturer Contact |
michele
seliga
|
1265 grey fox rd |
st. paul, MN 55112
|
6516287604
|
|
MDR Report Key | 5039308 |
MDR Text Key | 24438976 |
Report Number | 2183502-2015-00619 |
Device Sequence Number | 1 |
Product Code |
JOH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Respiratory Therapist
|
Report Date |
08/28/2015 |
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 |
No Information
|
Device Catalogue Number | ASKU |
Device Lot Number | ASKU |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/28/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|