MAUDE Adverse Event Report: SHASER, INC LUMARX; LIGHT BASED HAIR REMOVAL DEVICE

Model Number IPL6800USAQ

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Scarring (2061); Partial thickness (Second Degree) Burn (2694)

Event Date 03/04/2015

Event Type  Injury  

Event Description

User treated her face with ipl6800 hair removal device and sustained first and second degree burns, possibly resulting in permanent damage to her skin in the form of scarring.From the complaint: "consumer has lumarx and states she was burned to the point she had blisters on her face from it.Stated it was red after it was done woke up this morning blistered and black.Like curling iron burn.State she did not treat the same spot more than once." ref mfr#: 3009088196-2015-00001.

• Brand Name: LUMARX
• Type of Device: LIGHT BASED HAIR REMOVAL DEVICE
• Manufacturer (Section D): SHASER, INC; lexington MA
• Manufacturer (Section G): SPECTRUM BRANDS INC. A DELAWARE CORPORATION; 3001 deming way; middleton WI 53562 000
• Manufacturer Contact: 3001 deming way; middleton, WI 53562-0000
• MDR Report Key: 4698835
• MDR Text Key: 16633639
• Report Number: 3005855240-2015-00001
• Device Sequence Number: 1
• Product Code: ONF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IPL6800USAQ
• Device Catalogue Number: IPL6800USAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2015
• Distributor Facility Aware Date: 03/04/2015
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 04/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 34 YR
• Patient Weight: 76