CAPILLIUS 272 PRO HAIR REGROWTH LASER THERAPY CAP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for CAPILLIUS 272 PRO HAIR REGROWTH LASER THERAPY CAP manufactured by Capillus.

Event Text Entries

[54466485] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5064620
MDR Report Key5938958
Date Received2016-09-01
Date of Report2016-09-01
Date of Event2016-08-17
Date Added to Maude2016-09-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAPILLIUS 272 PRO HAIR REGROWTH LASER THERAPY CAP
Generic NameCAPILLIUS 272 PRO HAIR REGROWTH LASER THERAPY CAP
Product CodeOAP
Date Received2016-09-01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCAPILLUS
Manufacturer Address272 PRO


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-09-01

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