Brand Name | DRAINS OASIS SINGLE |
Type of Device | APPARATUS, AUTOTRANSFUSION |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
merrimack NH |
|
Manufacturer (Section G) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
|
merrimack NH |
|
Manufacturer Contact |
lori
gosselin
|
40 continental blvd |
merrimack, NH
|
|
MDR Report Key | 11572947 |
MDR Text Key | 242769077 |
Report Number | 3011175548-2021-00366 |
Device Sequence Number | 1 |
Product Code |
CAC
|
UDI-Device Identifier | 00650862110012 |
UDI-Public | 00650862110012 |
Combination Product (y/n) | N |
PMA/PMN Number | K043140 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
11/03/2022 |
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 Model Number | 3600-100 |
Device Catalogue Number | 3600-100 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/07/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/19/2021
|
Initial Date FDA Received | 03/25/2021 |
Supplement Dates Manufacturer Received | 06/07/2021 07/21/2021 11/03/2022
|
Supplement Dates FDA Received | 06/16/2021 07/24/2021 11/04/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|