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

[422761] The device is a hand operated syringe with a cannula for performing d&e, 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 of the plunger. 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 Number	621760
MDR Report Key	621760
Date Received	2005-07-13
Date of Report	2005-07-13
Date of Event	2005-07-01
Report Date	2005-07-13
Date Reported to FDA	2005-07-13
Date Added to Maude	2005-07-20
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Reporter Occupation	RISK MANAGER
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	MILEX UTERINE HANDY VAK SYSTEM
Generic Name	ASPIRATION CANNULA
Product Code	HFC
Date Received	2005-07-13
Model Number	*
Catalog Number	99070
Lot Number	39429
ID Number	*
Operator	PHYSICIAN
Device Availability	Y
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	611408
Manufacturer	MILEX PRODUCTS, INC.
Manufacturer Address	4311 N. NORMANDY CHICAGO IL 606341403 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-07-13