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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 LTC-1500
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Radiation Burn (1755)
Event Date 12/14/2018
Event Type  Injury  
Manufacturer Narrative
No product malfunction suspected.Device being returned for evaluation to confirm.Supplemental report will be issued when evaluation completed.
 
Event Description
Patient developed blister on foot that may have been contributed to by the subject device.
 
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Brand Name
LIGHTFORCE
Type of Device
THERAPY LASER
Manufacturer (Section D)
LITECURE, LLC
101 lukens drive
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 Key8437489
MDR Text Key139373520
Report Number3006268867-2019-00002
Device Sequence Number1
Product Code ILY
UDI-Device Identifier00854103007042
UDI-Public(01)00854103007042(11)180328
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 03/04/2019
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 Health Professional
Device Model NumberLTC-1500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age45 YR
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