Brand Name | HUDSN DUAL SPRAY MDI ADAPTOR |
Type of Device | METERED DOSE INHALER |
Manufacturer (Section D) |
TELEFLEX |
research triangle park NC 27709 |
|
Manufacturer (Section G) |
TELEFLEX |
2917 weck dr. |
|
research triangle park NC 27709 |
|
Manufacturer Contact |
margie
burton, rn
|
p.o. box 12600 |
research triangle park, NC 27709
|
9194334965
|
|
MDR Report Key | 3843259 |
MDR Text Key | 4411996 |
Report Number | 1044475-2014-00066 |
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,Distributor |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
03/03/2014 |
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 |
Other
|
Device Catalogue Number | 1759 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 03/03/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/03/2014
|
Initial Date FDA Received | 03/21/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | VENT |
|
|