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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IPL HAIRE REMOVER POWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT

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IPL HAIRE REMOVER POWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Burn, Thermal (2530)
Event Date 10/07/2017
Event Type  Injury  
Event Description
My wife has been going for laser hair treatment at radiance light systems, (b)(6). On (b)(6) 2017 when she went for laser treatment they literally burnt her skin i. E. On right hand there are (b)(6) burnt spots, left hand, (b)(6) burnt spots, right leg, (b)(6) burn spots, and left leg, (b)(6) burnt spots. I am going to upload lots of pictures. If i cannot attach it i have photos and video for me to upload or attach to this case.
 
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Brand NameIPL HAIRE REMOVER
Type of DevicePOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT
MDR Report Key6943982
MDR Text Key89249304
Report NumberMW5072734
Device Sequence Number0
Product Code ONF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 10/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2017
Is this an Adverse Event Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Type of Device Usage

Patient Treatment Data
Date Received: 10/12/2017 Patient Sequence Number: 1
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