Brand Name | HUDSON OPTI-NEB PRO COMPRESSOR W/ DISPOSABLE NE |
Type of Device | NEBULIZER COMPRESSOR |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
2917 weck dr. |
|
research triangle park NC 27709 |
|
Manufacturer Contact |
margie
burton, rn
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334965
|
|
MDR Report Key | 4523892 |
MDR Text Key | 5408362 |
Report Number | 1044475-2015-00095 |
Device Sequence Number | 1 |
Product Code |
CAF
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Consumer,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/26/2015 |
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 |
Lay User/Patient
|
Device Catalogue Number | 5900 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/26/2015
|
Initial Date FDA Received | 02/12/2015 |
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 |