Brand Name | LIFEVAC HOME KIT |
Type of Device | SUCTION APPARATUS |
Manufacturer (Section D) |
LIFEVAC LLC |
110 lake ave south, suite 35 |
nesconset NY 11767 |
|
Manufacturer (Section G) |
LIFEVAC LLC |
110 lake avenue south, suite 3 |
|
nesconset NY 11767 |
|
Manufacturer Contact |
stephen
oliveri
|
110 lake avenue south, suite 3 |
nesconset, NY 11767
|
5169651900
|
|
MDR Report Key | 16409910 |
MDR Text Key | 310157830 |
Report Number | 3011053282-2022-00001 |
Device Sequence Number | 1 |
Product Code |
GCX
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/05/2022 |
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 |
Lay User/Patient
|
Device Model Number | LVC3001 |
Device Lot Number | 220625 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/21/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 Age | 9 YR |
Patient Sex | Male |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|