HUT EXT DR FINAL ASSY-REVERSE 404007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-02-14 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim Co..

Event Text Entries

[17098622] On (b)(6): customer reports via phone that during an unspecified urology procedure with a female patient, the fluoro failed. Customer reports the physician completed the procedure by use of endoscopy. Customer provided no further information other than to say the procedure was completed and patient is fine.
Patient Sequence No: 1, Text Type: D, B5


[17400611] 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 Number1518293-2012-00023
MDR Report Key2462719
Report Source05,06,07
Date Received2012-02-14
Date of Report2012-02-14
Date of Event2012-01-20
Date Mfgr Received2012-01-20
Device Manufacturer Date2002-04-01
Date Added to Maude2012-08-16
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 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-REVERSE
Product CodeKQS
Date Received2012-02-14
Model NumberHUT EXT DR
Catalog Number404007
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2012-02-14

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