MILEX UTERINE HANDY VAK SYSTEM * 99070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-13 for MILEX UTERINE HANDY VAK SYSTEM * 99070 manufactured by Milex Products, Inc.

Event Text Entries

[417762] The device is a hand operated syringe with a cannula for performing d&es, dilation and evacuation. After the cannula is introduced into the uterus, suction is applied by pulling back on the plunger handle while holding the syringe barrel steady in the uterus. On initiating suction, the handle pulled away from the rubber stopper. The counter pressure on the barrel caused the cannula to be pushed further into the uterus. The patient was not harmed because the doctor prevented the cannula from pushing through the uterine wall.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number621761
MDR Report Key621761
Date Received2005-07-13
Date of Report2005-07-13
Date of Event2005-07-11
Report Date2005-07-13
Date Reported to FDA2005-07-13
Date Added to Maude2005-07-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMILEX UTERINE HANDY VAK SYSTEM
Generic NameASPIRATION CANNULA
Product CodeHFC
Date Received2005-07-13
Model Number*
Catalog Number99070
Lot Number41406
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key611409
ManufacturerMILEX PRODUCTS, INC
Manufacturer Address4311 N. NORMANDY CHICAGO IL 606341403 US


Patients

Patient NumberTreatmentOutcomeDate
10 2005-07-13

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