TRU-CLOSE SUCTION DRAINAGE SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for TRU-CLOSE SUCTION DRAINAGE SYSTEM manufactured by Uresil, Llc.

Event Text Entries

[184263964] Accordion drain placed in abscess continues to leak at drainage site because it does not close all the way.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9859572
MDR Report Key9859572
Date Received2020-03-20
Date of Report2020-02-13
Date of Event2020-02-11
Report Date2020-02-13
Date Reported to FDA2020-02-13
Date Reported to Mfgr2020-03-20
Date Added to Maude2020-03-20
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

Brand NameTRU-CLOSE SUCTION DRAINAGE SYSTEM
Generic NameAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Product CodeGCY
Date Received2020-03-20
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerURESIL, LLC
Manufacturer Address5418 W. TOOHY AVE. SKOKIE IL 60077 US 60077


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-20

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