SUSAN LUCCI DERMABRASION KIT UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-15 for SUSAN LUCCI DERMABRASION KIT UNK manufactured by Unk.

Event Text Entries

[618624] I purchased a home dermabrasion kit and have caused what appears to be irrepairable harm to my skin. I am currently on steroids to keep the inflammation in check. Without the steroid my face is beat red bordering on purple on some sections. My face is on fire and from this red drying i have acne. I can not be in the sun. Which restricts my life a good part of the year. And it's not just the sun, it is heat too. The product did not have adequate warning on the package. All it mentioned was that if one has rosacea, it may be aggravated. I subsequently discovered that these products should not be used by anyone who blushes or gets flushed easily, which i do. That this product is really made for removing scars. I used this product a total of three times. The first time i did not see any difference just a little bit of dryness which went away. The second time i used the product, i had the same result. The third time, it just irritated my complexion and it has never recovered. I used this product in monthly intervals so that i would not cause damage to my skin, but obviously, i was wrong. The product i used was purchased from an infomercial. But, i am certain that any one of the similar products would have the same effect. I want to have any home dermabrasion kit taken off the market.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5001876
• MDR Report Key: 852250
• Date Received: 2007-05-15
• Date of Report: 2007-05-15
• Date of Event: 2003-04-15
• Date Added to Maude: 2007-06-11
• 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
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUSAN LUCCI DERMABRASION KIT
• Generic Name: DERMABRASION KIT
• Product Code: GFE
• Date Received: 2007-05-15
• Returned To Mfg: 2003-04-30
• Model Number: UNK
• Operator: LAY USER/PATIENT
• Device Availability: R
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 840339
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2007-05-15