EXPRESS 4000-100N

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-10 for EXPRESS 4000-100N manufactured by Atrium Medical Corporation.

MAUDE Entry Details

Report Number8775310
MDR Report Key8775310
Date Received2019-07-10
Date of Report2019-07-05
Date of Event2019-06-27
Report Date2019-07-05
Date Reported to FDA2019-07-05
Date Reported to Mfgr2019-07-10
Date Added to Maude2019-07-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXPRESS
Generic NameBOTTLE, COLLECTION, VACUUM
Product CodeKDQ
Date Received2019-07-10
Model Number4000-100N
Lot Number443611
Device Availability*
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 2019-07-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.