VECTOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-23 for VECTOR * manufactured by Vector.

Event Text Entries

[340980] Consumer bought device from internet. Followed written dfu. After one year of use, has seen no change to hair growth. Complains of redness, itching and intermittent burning to upper lip and chin. Returned device to mfr and has not rec'd reimbursement to date. States website now contains fda warning about product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030716
• MDR Report Key: 505866
• Date Received: 2003-12-31
• Date of Report: 2003-12-23
• Date of Event: 2002-10-01
• Date Added to Maude: 2004-01-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: VECTOR
• Generic Name: ELECTROLYSIS
• Product Code: KCX
• Date Received: 2003-12-23
• Returned To Mfg: 2003-10-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 494734
• Manufacturer: VECTOR
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-12-31