Brand Name | OASIS |
Type of Device | DRAIN, DRY TOTAL RECOVERY W/AC |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
merrimack NH 03054 |
|
Manufacturer (Section G) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd. |
|
merrimack NH 03054 |
|
Manufacturer Contact |
lori
gosselin
|
40 continental blvd. |
merrimack, NH 03054
|
6038645366
|
|
MDR Report Key | 6703667 |
MDR Text Key | 79729989 |
Report Number | 3011175548-2017-00016 |
Device Sequence Number | 1 |
Product Code |
CAC
|
UDI-Device Identifier | 00650862113013 |
UDI-Public | 00650862113013 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K043140 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/11/2017 |
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 |
Physician
|
Device Model Number | 3650-100 |
Device Catalogue Number | 3650-100 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/03/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/06/2017
|
Initial Date FDA Received | 07/11/2017 |
Supplement Dates Manufacturer Received | 08/15/2017
|
Supplement Dates FDA Received | 08/24/2017
|
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 Outcome(s) |
Required Intervention;
|
|
|