Brand Name | CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD |
Type of Device | CONNECTOR, AIRWAY (EXTENSION) |
Manufacturer (Section D) |
VYAIRE MEDICAL, INC |
26125 n riverqwood |
mettawa IL 60045 |
|
Manufacturer (Section G) |
VYAIRE MEDICAL, INC |
cerrada via de la produccion |
no. 85 parque industrial mex |
mexicali baja california norte |
MX
|
|
Manufacturer Contact |
mindy
faber
|
26125 n riverwood blvd |
mettawa, IL 60045
|
|
MDR Report Key | 7262957 |
MDR Text Key | 99777155 |
Report Number | 8030673-2018-00411 |
Device Sequence Number | 1 |
Product Code |
BZA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/12/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 004081-A |
Device Lot Number | 0001129863 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/05/2018
|
Initial Date FDA Received | 02/12/2018 |
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) |
Required Intervention;
|