REJUVASILK 200 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-12 for REJUVASILK 200 * manufactured by Medical Alliance, Inc..

Event Text Entries

[202668] The consumer got a flier in the mail for microdermabrasion from a dermatologist, and decided to have slightly sun-damaged skin treated. Had one treatment and about 1-1/2 weeks later noted that they had hair stubble all over face as if they had shaved their face. Went back to the dermatologist, who told them they had a hormone problem. Went to another dermatologist who has been doing electrolysis to remove the hairs, but they are too numerous and coarse, especially on nose and under chin. The second dermatologist and the consumer's gynecologist did not think they had a hormone problem, and believed hair follicles were damaged during the microdermabrasion. Trauma to hair follicles caused coarse hair growth on face; complainant filed a complaint against the dermatologist.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002926
• MDR Report Key: 312959
• Date Received: 2001-01-12
• Date of Report: 2001-01-02
• Date of Event: 2000-09-14
• Date Added to Maude: 2001-01-23
• 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: 0
• Reporter Occupation: PATIENT
• 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: REJUVASILK 200
• Generic Name: MICRODERMABRASION SYSTEM
• Product Code: GFE
• Date Received: 2001-01-12
• Model Number: *
• Catalog Number: *
• Lot Number: 1742
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 302713
• Manufacturer: MEDICAL ALLIANCE, INC.
• Manufacturer Address: 2445 GATEWAY DR STE 150 IRVING TX 75063 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-01-12