Brand Name | HUDSON NEB ADAPTOR 028, NON-STERILE, SHELFPAK |
Type of Device | NEBULIZER (DIRECT PATIENT INTE |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
morrisville NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
parque industrial finsa |
|
nuevo laredo 88275 |
MX
88275
|
|
Manufacturer Contact |
victoria
sandlin
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 9224565 |
MDR Text Key | 198513494 |
Report Number | 3004365956-2019-00288 |
Device Sequence Number | 1 |
Product Code |
CAF
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K141214 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,user faci |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/03/2019 |
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 |
No Information
|
Device Catalogue Number | 031-28 |
Device Lot Number | 74K1801112 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
10/03/2019
|
Initial Date FDA Received | 10/23/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/05/2018 |
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 |