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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LITECURE LITECURE THERAPEUTIC LASER

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LITECURE LITECURE THERAPEUTIC LASER Back to Search Results
Model Number LCT-1000
Device Problems Fire (1245); Melted (1385); Electrical Shorting (2926)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2017
Event Type  Injury  
Event Description
Therapeutic laser cable at the connector where the cord attaches to the unit caught fire and melted due to a "short. " pt treatment ceased during the occurrence. No pt injury occurred.
 
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Brand NameLITECURE
Type of DeviceTHERAPEUTIC LASER
Manufacturer (Section D)
LITECURE
newark DE 19702
MDR Report Key6300004
MDR Text Key66475148
Report NumberMW5067628
Device Sequence Number1
Product Code ILY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLCT-1000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/01/2017 Patient Sequence Number: 1
Treatment
IDENTIFYING MARKS: (B)(4); LASER TREATMENT HEAD AND CORD,
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