Brand Name | WATER STERILE FOR INHALATION 500ML |
Type of Device | NEBULIZER (DIRECT PATIENT INTERFACE) |
Manufacturer (Section D) |
VYAIRE MEDICAL |
510 technology dr |
irvine IL 92618 |
|
Manufacturer (Section G) |
LABORATORIOS PISA S.A. DE C.V. |
calle 7 n0. 1308 |
zona industrial |
guadalajara jalisco, 44940 |
MX
44940
|
|
Manufacturer Contact |
erika
bonilla
|
510 technology dr |
irvine, IL 92618
|
7149227837
|
|
MDR Report Key | 14190933 |
MDR Text Key | 289952851 |
Report Number | 3005440755-2022-00001 |
Device Sequence Number | 1 |
Product Code |
CAF
|
UDI-Device Identifier | 10190752141780 |
UDI-Public | (01)10190752141780(10)ZI-2108234 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K830895 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/24/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/22/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | WATER STERILE FOR INHALATION 500ML |
Device Catalogue Number | CN0005 |
Device Lot Number | ZI-2108234 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 03/24/2022 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
Patient Outcome(s) |
Other;
|