DRAINS OASIS SINGLE 3600-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-05 for DRAINS OASIS SINGLE 3600-100 manufactured by Atrium Medical Corporation.

Event Text Entries

[181978409] A follow up report will be submitted upon completion of the investigation into this event.
Patient Sequence No: 1, Text Type: N, H10


[181978410] Received a report that the drain came out of the package with a defective suction nozzle.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011175548-2020-00250
MDR Report Key9672224
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-05
Date of Report2020-02-05
Date Mfgr Received2020-01-30
Device Manufacturer Date2019-02-27
Date Added to Maude2020-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal03054
Manufacturer G1ATRIUM MEDICAL CORPORATION
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal Code03054
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRAINS OASIS SINGLE
Generic NameAPPARATUS, AUTOTRANSFUSION
Product CodeCAC
Date Received2020-02-05
Returned To Mfg2020-02-11
Model Number3600-100
Catalog Number3600-100
Lot Number443360
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerATRIUM MEDICAL CORPORATION
Manufacturer Address40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

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