MAUDE Adverse Event Report: CURALLUX, LLC CAPILLUSPRO; LASER, COMB, HAIR

Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Date of Event	10/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient called to report an adverse event she experienced using a laser cap for hair growth.Reporter said that she was using this device since (b)(6) of this year.Reporter said on or about (b)(6) of 2020 she started having sensitivity to light, skin itching.She said she did not know it had to do with the device until she stopped using it after she traveled at the end of (b)(6).She said she got better when she stopped using the device.When she started using it again in (b)(6), she said she had another outbreak, itching, welts, red all over her face and peeling skin.She said she also had another episode on (b)(6), incredible sensitivity to sun light even though she worn sunscreen, welts, itching.She said it almost took 2 weeks to heal.The reporter said the device did not work at all.

• Brand Name: CAPILLUSPRO
• Common Device Name: LASER, COMB, HAIR
• Manufacturer (Section D): CURALLUX, LLC
• MDR Report Key: 11147440
• Report Number: MW5098754
• Device Sequence Number: 3903184
• Product Code: OAP
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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?: Yes
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2021
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 67