Brand Name | HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE |
Type of Device | ADAPTOR |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
parque industrial finsa |
|
nuevo laredo 8827 5 |
MX
88275
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334854
|
|
MDR Report Key | 4898234 |
MDR Text Key | 20810709 |
Report Number | 3004365956-2015-00179 |
Device Sequence Number | 1 |
Product Code |
CAF
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
06/22/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/08/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 02/28/2020 |
Device Catalogue Number | 031-33J |
Device Lot Number | 74B1503150 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/06/2015 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/24/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/23/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|