MILEX UTERINE HANDY-VAC SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-10 for MILEX UTERINE HANDY-VAC SYSTEM * manufactured by Milex Products.

Event Text Entries

[400403] The product, milex uterine handy-vac system 6mm, plunger broke on aspiration. A 5mm device was then tried. The plunger broke with the 5mm. The doctor finished with a 7mm device. This device functioned correctly. Two weeks earlier, the same lot 5mm device failed to provide suction, nearly causing a uterine perforation. Five 5mm devices were tried. Three had similar problems.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 619809
• MDR Report Key: 619809
• Date Received: 2005-06-10
• Date of Report: 2005-06-10
• Date of Event: 2005-06-07
• Report Date: 2005-06-10
• Date Reported to FDA: 2005-06-10
• Date Added to Maude: 2005-07-08
• 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: 3
• 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 Sequence Number: 1

• Brand Name: MILEX UTERINE HANDY-VAC SYSTEM
• Generic Name: ASPIRATION SYSTEM (CANNULA SYRINGE)
• Product Code: HFC
• Date Received: 2005-06-10
• Model Number: *
• Catalog Number: *
• Lot Number: 39487 5MM
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 609494
• Manufacturer: MILEX PRODUCTS
• Manufacturer Address: 4311 N. NORMANDY CHICAGO IL 60634 US

Device Sequence Number: 2

• Brand Name: UTERINE HANDYVAC
• Generic Name: ASPIRATION SYSTEM (CANNULA SYRINGE)
• Product Code: HFC
• Date Received: 2005-06-10
• Model Number: *
• Catalog Number: *
• Lot Number: 39429 6MM
• ID Number: *
• Device Availability: N
• Device Age: 2 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 609495
• Manufacturer: MILEX PRODUCTS INC.
• Manufacturer Address: 4311 N NORMANDY CHICAGO IL 60634 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-06-10