Brand Name | AIRLIFE¿ MISTY MAX 10¿ NEBULIZER, MEDICATION SYSTEM WITH FILTER |
Type of Device | NEBULIZER (DIRECT PATIENT INTERFACE) |
Manufacturer (Section D) |
VYAIRE MEDICAL |
510 technology dr |
irvine IL 92618 |
|
Manufacturer (Section G) |
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
cerrada via de la produccion |
no. 85, parque undustrial mex |
mexicali, |
MX
|
|
Manufacturer Contact |
erika
bonilla
|
510 technology dr |
irvine, IL 92618
|
7149227837
|
|
MDR Report Key | 14432002 |
MDR Text Key | 300260005 |
Report Number | 8030673-2022-00244 |
Device Sequence Number | 1 |
Product Code |
CAF
|
UDI-Device Identifier | 10190752114944 |
UDI-Public | (01)10190752114944(10)0004147582 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K023602 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
04/19/2022 |
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 |
Health Professional
|
Device Model Number | AIRLIFE¿ MISTY MAX 10¿ NEBULIZER, MEDICATION SYSTEM WITH FILTER |
Device Catalogue Number | 002450 |
Device Lot Number | 0004147582 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/19/2022
|
Initial Date FDA Received | 05/18/2022 |
Supplement Dates Manufacturer Received | 05/11/2022
|
Supplement Dates FDA Received | 06/06/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |