DBAG600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for DBAG600 manufactured by Argon Medical Devices, Inc..

Event Text Entries

[110924005]
Patient Sequence No: 1, Text Type: N, H10


[110924006] Drainage bag leaked in several places.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7595916
MDR Report Key7595916
Date Received2018-06-13
Date of Report2018-05-18
Date of Event2018-04-23
Report Date2018-05-09
Date Reported to FDA2018-05-09
Date Reported to Mfgr2018-05-09
Date Added to Maude2018-06-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameBAG, DRAINAGE
Product CodeEXF
Date Received2018-06-13
Model NumberDBAG600
Catalog NumberDBAG600
Lot Number11208564
OperatorNURSE
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARGON MEDICAL DEVICES, INC.
Manufacturer Address1445 FLAT CREEK ROAD ATHENS TX 75751 US 75751


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-13

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