Brand Name | PORTEX BIVONA FLEXTEND TTS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES |
Type of Device | JOH-TRACHEOSTOMY TUBES |
Manufacturer (Section D) |
SMITHS MEDICAL, INC., |
gary IN |
|
Manufacturer (Section G) |
SMITHS MEDICAL MD, INC. |
5700 west 23rd ave |
|
gary IN 46406 |
|
Manufacturer Contact |
pete
hirte
|
st. paul, MN 55112
|
6516287384
|
|
MDR Report Key | 4681860 |
MDR Text Key | 5688768 |
Report Number | 2183502-2015-00216 |
Device Sequence Number | 1 |
Product Code |
JOH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K944178 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Lay User/Patient
|
Type of Report
| Initial |
Report Date |
04/06/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/06/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 60PFSS35 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/06/2015 |
Event Location |
Home
|
Date Manufacturer Received | 03/16/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 1 YR |
|
|