Brand Name | OASIS SINGLE DRAIN |
Type of Device | APPARATUS, AUTOTRANSFUSION |
Manufacturer (Section D) |
ATRIUM MEDICAL |
40 continental blvd |
merrimack NH 03054 |
|
Manufacturer (Section G) |
ATRIUM MEDICAL |
40 continental blvd |
|
merrimack NH 03054 |
|
Manufacturer Contact |
|
40 continental blvd |
merrimack, NH 03054
|
|
MDR Report Key | 7639435 |
MDR Text Key | 112412358 |
Report Number | 3011175548-2018-00648 |
Device Sequence Number | 1 |
Product Code |
CAC
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K043140 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/26/2018 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/08/2021 |
Device Model Number | 3600-100 |
Device Catalogue Number | 3600-100 |
Device Lot Number | 426795 |
Other Device ID Number | 00650862110012 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/06/2018 |
Initial Date FDA Received | 06/26/2018 |
Supplement Dates Manufacturer Received | 07/03/2018
|
Supplement Dates FDA Received | 07/18/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/15/2018 |
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|