SILK'N BLUE ACNE SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-30 for SILK'N BLUE ACNE SOLUTION manufactured by Home Skinovations.

Event Text Entries

[84255203] I was using silk'n blue acne solution device on my face for treating my acne. I followed the device instructions and safety hazards manual. I was using the device once a day as recommended, on facial areas which the device intended for, also on my forehead, on pimples i had near my hairline. After about 4 weeks, i noticed thinning and reduction of my hairline, especially on sides. I never had a thinning hair on these areas or in other areas of my scalp. Beside the silk'n device treatment, i did not change anything in my routine. I am very convinced that the hairline thinning is a cause of using the device. In photos of mine which taken a few weeks before i started using the device. I clearly see the difference: my hairline was lower, and i had no thinning hair on sides. I ask you to help me with the problem above because i don't know if the damage is reversible, and it is depressing me a lot. I even don't know how to treat this damage, because i don't know which functio of the device harmed my hair. If you can, please let me know if there was any similar complaints about the silk'n blue acne device, and what can i do about the damage i described. Even if i am the first person who complains about that device. I ask you please to test again the device or tell silk'n company to add warning about that possible side effect, so it will not cause any damage to someone else.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071850
• MDR Report Key: 6830658
• Date Received: 2017-08-30
• Date of Report: 2017-08-27
• Date of Event: 2017-05-23
• Date Added to Maude: 2017-08-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• 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 Sequence Number: 0

• Brand Name: SILK'N BLUE ACNE SOLUTION
• Generic Name: OVER-THE-COUNTER POWERED LIGHT BASED LASER FOR ACNE
• Product Code: OLP
• Date Received: 2017-08-30
• Device Expiration Date: 2017-04-25
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: HOME SKINOVATIONS

Device Sequence Number: 1

• Brand Name: SILK'N BLUE ACNE SOLUTION
• Generic Name: DERMABRASION BRUSH
• Product Code: OLP
• Date Received: 2017-08-30
• Device Expiration Date: 2017-04-25
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HOME SKINOVATIONS

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-08-30