Brand Name | OCEAN DRAIN |
Type of Device | BOTTLE, COLLECTION, VACUUM |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
merrimack NH 03054 |
|
MDR Report Key | 9432731 |
MDR Text Key | 190342357 |
Report Number | 3011175548-2019-01217 |
Device Sequence Number | 1 |
Product Code |
KDQ
|
UDI-Device Identifier | 00650862100105 |
UDI-Public | 00650862100105 |
Combination Product (y/n) | N |
PMA/PMN Number | K043582 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
12/06/2019 |
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 | 01/25/2021 |
Device Model Number | 2002-300 |
Device Catalogue Number | 2002-300 |
Device Lot Number | 426306 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/23/2020 |
Initial Date Manufacturer Received |
12/03/2019
|
Initial Date FDA Received | 12/06/2019 |
Supplement Dates Manufacturer Received | 01/23/2020 01/23/2020 03/06/2020
|
Supplement Dates FDA Received | 02/20/2020 02/20/2020 03/17/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |