PMD PERSONAL MICRODERM NONE LISTED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-23 for PMD PERSONAL MICRODERM NONE LISTED manufactured by Age Sciences Inc..

Event Text Entries

[29923377] I purchased a pmd microdermabrasion device. I strictly followed the instructions. I experienced a slight sensation while using the device as the instruction manual stated i would. Upon completion of the treatment my skin had a reddish color with slight burning sensation. As the day progressed the burning sensation increased and swelling appeared. The burning sensation required pain medication as well as icing of the skin. I was unable to go to work for 2 days. This device is dangerous for at home and use and should not be used by non-professionals. There is no warning in the instructions that this type of injury could occur. Three days after the home treatment, my skin is scabbed and possibly scarred, i am monitoring for infection. I contacted the company, and the manager i spoke with indicated that his girlfriend had the same problem. They are aware of this problem, yet they chose not to alert consumers to the possibility of serious injury. The company representative was supposed to call me back to day, but failed to do so, when i called their offices, no one was there. I'm not sure if this is a fly by night company, but they are unwilling to stand behind their product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5057540
• MDR Report Key: 5187619
• Date Received: 2015-10-23
• Date of Report: 2015-10-23
• Date of Event: 2015-10-20
• Date Added to Maude: 2015-10-29
• 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: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PMD PERSONAL MICRODERM
• Generic Name: PMD PERSONAL MICRODERM
• Product Code: GFE
• Date Received: 2015-10-23
• Model Number: NONE LISTED
• Catalog Number: NONE LISTED
• Lot Number: NONE LISTED
• ID Number: 5539400328
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AGE SCIENCES INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-10-23