MAUDE Adverse Event Report: LEXINGTON HAIRMAX LASER COMB

Model Number PROFESSIONAL 12

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Hair Loss (1877); Inflammation (1932); Pain (1994); Discomfort (2330)

Event Date 04/01/2015

Event Type  Injury  

Event Description

I have been using hairmax laser comb for 9 months and my hair is getting worse than ever.All my hair becomes so thin an increase hair loss, but hairmax asked me to keep using it.My dermatologist asked me to stop using it and my hair condition may be caused by the laser comb.

• Brand Name: HAIRMAX LASER COMB
• Type of Device: HAIRMAX LASER COMB
• Manufacturer (Section D): LEXINGTON
• MDR Report Key: 5001274
• MDR Text Key: 22955389
• Report Number: MW5055332
• Device Sequence Number: 1
• Product Code: OAP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PROFESSIONAL 12
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 64