Brand Name | HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV |
Type of Device | SMALL VOLUME NEBULIZER |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
nuevo laredo |
MX |
|
Manufacturer (Section G) |
TELEFLEX |
ave. transformacion 5954 |
parque industrial finsa |
nuevo laredo 8827 5 |
MX
88275
|
|
Manufacturer Contact |
margie
burton, ra, cs
|
p.o. box 12600 |
durham, NC 27709
|
9194334965
|
|
MDR Report Key | 3865189 |
MDR Text Key | 4510698 |
Report Number | 3004365956-2014-00062 |
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 |
User Facility,Company Representative |
Reporter Occupation |
Not Applicable
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
01/22/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/11/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | 1734 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 01/30/2014 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 01/22/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|