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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LITECURE, LLC LIGHTFORCE THERAPY LASER

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LITECURE, LLC LIGHTFORCE THERAPY LASER Back to Search Results
Model Number LTS-2500
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Radiation Burn (1755)
Event Date 01/17/2019
Event Type  Injury  
Manufacturer Narrative
Device returned for evaluation and no quality issues found. Device safety functions and performance were within specifications. Reported injury caused by known risk inherent with device type and documented in labeling and risk management. Incident type will be further analyzed through post market surveillance process.
 
Event Description
Patient experienced lesion on shoulder several days after treatment due to incorrect procedure by operator. The provided dose was greater than the recommended level leading to overexposure. Treatment technique did not follow ifu. Also, patient had reduced sensation due to existing condition that was not disclosed prior to treatment.
 
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Brand NameLIGHTFORCE
Type of DeviceTHERAPY LASER
Manufacturer (Section D)
LITECURE, LLC
101 lukens dr
suite a
new castle DE 19720 2791
Manufacturer (Section G)
LITECURE, LLC
101 lukens drive
suite a
new castle DE 19720 2791
Manufacturer Contact
eric rock
101 lukens drive
suite a
new castle, DE 19720-2791
3027090408
MDR Report Key8437526
MDR Text Key139359892
Report Number3006268867-2019-00001
Device Sequence Number1
Product Code ILY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberLTS-2500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/20/2019 Patient Sequence Number: 1
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