HUT EXT DR FINAL ASSY-STANDARD 404008

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-12-22 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim Co.

Event Text Entries

[2429591] On (b)(6), customer reports via phone - approx (b)(6) male having a urology procedure, including stent placements when the system fluoro failed. Physician completed the procedure using endoscopy to place the stents. Stent placement was confirmed using flat plate x-rays. No reported injury.
Patient Sequence No: 1, Text Type: D, B5


[9531206] Pending investigation. Upon receipt of investigation, a medwatch 3500a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1518293-2011-00246
MDR Report Key2422630
Report Source06,07
Date Received2011-12-22
Date of Report2011-12-22
Date of Event2011-12-02
Date Mfgr Received2011-12-02
Device Manufacturer Date2008-02-01
Date Added to Maude2012-07-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactDAVID BENSON
Manufacturer Street2111 EAST GALBRAITH RD.
Manufacturer CityCINCINNATI OH 45237
Manufacturer CountryUS
Manufacturer Postal45237
Manufacturer Phone5139485719
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUT EXT DR FINAL ASSY-STANDARD
Generic NameUROLOGY SUITE
Product CodeKQS
Date Received2011-12-22
Model NumberHUT EXT DR
Catalog Number404008
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerLIEBEL-FLARSHEIM CO
Manufacturer Address2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237


Patients

Patient NumberTreatmentOutcomeDate
10 2011-12-22

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