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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LITECURE CLASS IV LASER TREATMENT THE LCT-1000; LAMP INFRARED, THERAPEUTIC HEATING
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LITECURE CLASS IV LASER TREATMENT THE LCT-1000; LAMP INFRARED, THERAPEUTIC HEATING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Burning Sensation (2146); Dizziness (2194); Discomfort (2330); Palpitations (2467); Ambulation Difficulties (2544)
Event Date 02/08/2017
Event Type  Injury  
Event Description
I have lower back problem and went to physical therapy.The therapist had laser therapy using lct 1000 by litecure company on my lower back.I think, i had laser treatment about 5 minutes.During treatment, i experienced discomfort in my heart, and my heart started pounding.After treatment, i had dizziness, headache and nausea, and my heart kept pounding hard.I felt very, very tired and did not want to do anything, just lied in bed.Treated area felt very warm, and had burning and stinging pain.My lower back pain increased after treatment, i had difficulty in walking and even sitting.Treated area (skin) looks brownish.After a day, my pain is still severe.Burning and stinging pain in treated area.Hard to walk and sit.
 
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Brand Name
CLASS IV LASER TREATMENT THE LCT-1000
Type of Device
LAMP INFRARED, THERAPEUTIC HEATING
Manufacturer (Section D)
LITECURE
MDR Report Key6325814
MDR Text Key67370323
Report NumberMW5067844
Device Sequence Number1
Product Code ILY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age50 YR
Patient Weight38
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