MAUDE Adverse Event Report: CAPILLUS CAPILLIUS 272 PRO HAIR REGROWTH LASER THERAPY CAP

Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Headache (1880); Discomfort (2330)
Date of Event	08/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Good day sir or madam.As per my doctor's instructions, i'm reaching out to you, the fda, with regards my experience with the capillus 272 pro laser cap.With great enthusiasm i bought the capillus 272 laser cap for (b)(6) dollars on (b)(6) 2016 from my doctor's clinic, (b)(6).Starting on (b)(6), i was able to use it up to 7 sessions until i had to stop due to the painful headaches it produced.I wore it as prescribed by my doctor: 3 times a week, 30-minutes each session.During the first 5-minutes into the sessions, i experienced mild headaches that also lingered past the sessions.Though i rarely get headaches (because i'm a healthy individual), these got more significant in pain with each session during the 3 weeks of use.Today, (b)(6) 2016 i returned the 272 cap (serial number (b)(4)) but my headache is still with me despite having last used the cap on (b)(6) 2016 (4 days ago).The ache persisted and persists throughout the day and night.I wake up with the stubborn headache.The pain is temporarily localized to a particular part in my head for a time, it comes and goes; it then appears in another part of my head, also comes and goes.Sometimes the pain is dull and it nags, sometimes the pain is sharp.It feels like a mild migraine.When i first got the headaches i ignored them just because i thought it's part of getting used to the therapy, there is also a large part of me wanting to have this product work out to help my hair from falling.So i really gave this product the benefit of the doubt.But i got really worried about it when the pain persisted and grew, so to test things out, i asked my mother to try the 272 cap, twice: she also felt the same headaches, both times.She event felt pain on her face.This confirmed that there is indeed a problem.I reached out to capillus and they tell me, contrary to their website that says there are no known side effects, this is a common occurrence.They kindly instructed me to split the 30 minute daily session into two 15 minute sessions via email (i can forward it if necessary).I followed the counsel, but discovered the same discomfort in just the first 5 minutes into the therapy.On a separate note, my mother also bought a cap, except hers is the 82 laser diodes version (as opposed to mine with 272 diodes), and i tried hers.I felt no discomfort wearing the lower dosage, nor did i feel the same discomfort under my doctor's dome, which is the doctor's version of the cap which is suspended above the head, rather than sit directly on the head.Took propecia for 8 days on (b)(6) 2016 but testicular pain made me stop, which continues to linger by the way, 3 weeks after stopping.Applying rogaine for 2 weeks as of today, (b)(6) 2016.

• Brand Name: CAPILLIUS 272 PRO HAIR REGROWTH LASER THERAPY CAP
• Common Device Name: CAPILLIUS 272 PRO HAIR REGROWTH LASER THERAPY CAP
• Manufacturer (Section D): CAPILLUS; 272 pro
• MDR Report Key: 5938958
• Report Number: MW5064620
• Device Sequence Number: 769652
• Product Code: OAP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRUG FREE, VITAMINS; OTC MEDS: VIVISCAL; ROGAINE; RX MEDS: PROPECIL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Weight: 65