Brand Name | DRAINS OASIS SINGLE |
Type of Device | APPARATUS, AUTOTRANSFUSION |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
merrimack NH 03054 |
|
MDR Report Key | 10517935 |
MDR Text Key | 207379721 |
Report Number | 3011175548-2020-01131 |
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 |
company representative,health |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
09/10/2020 |
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 |
Health Professional
|
Device Expiration Date | 05/14/2023 |
Device Model Number | 3600-100 |
Device Catalogue Number | 3600-100 |
Device Lot Number | 458632 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/21/2020 |
Initial Date Manufacturer Received |
09/02/2020 |
Initial Date FDA Received | 09/10/2020 |
Supplement Dates Manufacturer Received | 09/10/2020 09/21/2020 01/24/2021
|
Supplement Dates FDA Received | 09/11/2020 09/26/2020 02/04/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 78 YR |
Patient Weight | 49 |