Brand Name | HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA |
Type of Device | PEAK FLOW METER |
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
|
po box 12600 |
rtp, NC 27709
|
9194334965
|
|
MDR Report Key | 4132993 |
MDR Text Key | 4950267 |
Report Number | 1044475-2014-00274 |
Device Sequence Number | 1 |
Product Code |
BZH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional,User Facility,Distributor |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
09/08/2014 |
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 |
Lay User/Patient
|
Device Expiration Date | 05/01/2012 |
Device Catalogue Number | 1801 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 09/17/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/08/2014
|
Initial Date FDA Received | 09/29/2014 |
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 |
Initial
|
Patient Sequence Number | 1 |
|
|