MAUDE Adverse Event Report: LASER HAIR REMOVAL; POWERED LASER SURGICAL INSTRUMENT

Device Problems Labelling, Instructions for Use or Training Problem (1318); Patient-Device Incompatibility (2682)

Patient Problems Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/12/2015

Event Type  Injury  

Event Description

Went to a laser hair removal in (b)(6) to treat peach fuzz on face and hair on legs.Shortly after experienced paradoxical hypertrichosis.The clinic failed to mention this could be a side effect, although very rare for someone with my skin type.Tried to contact the clinic multiple times regarding my concern that one the hair on my legs grew even more after treatment and two the hair on my face started to grow and come in dark.Went to multiple doctors to see if it was a hormonal issue, but this was not the case.Currently being treated for the paradoxical hypertricosis using electrolysis.Laser hair removal should be more regulated and clinics should provide warnings that paradoxical hypertrichosis is a side effect.The clinic also fails to give my money back.Tested multiple times with normal values.Laser for less.

• Brand Name: LASER HAIR REMOVAL
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• MDR Report Key: 13019783
• MDR Text Key: 282420898
• Report Number: MW5106112
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MULTI-VITAMIN; OMEGA 3
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White