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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-14 for * manufactured by *.

Event Text Entries

[374450] In 2003 (summer), pt had 5 micro-dermabrasion treatments in a spa owned by a dermatologist. He had suggested this procedure to remove acne scars. The treatments were painful, but pt continued through the 5th treatment, as he had suggested. Within a month of completing the treatments, pt developed a horrible, extremely painful disease called facial neuralgia on the left side of their face. Although pt has only had several attacks of the debilitating pain, the inside of their left cheek remains constantly raw and will not heal. Neurologist suggested that it was possible that bacteria seeped into the underlying nerves during the treatments, possibly causing this disease. Pt asks if these treatments are fda approved, if any studies have been done to test the safety of this procedure, finally if the spas and clinics which perform this procedure licensed and evaluated by anyone. Pt really thinks this needs to be researched and examined. Pt would hate for anyone to go through the pain they are now subjected to.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1034927
• MDR Report Key: 584462
• Date Received: 2005-03-14
• Date of Event: 2003-01-01
• Date Added to Maude: 2005-03-25
• 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: 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: *
• Generic Name: MICRODERMABRASION TREATMENT
• Product Code: GFE
• Date Received: 2005-03-14
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 574293
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-03-14