MAUDE Adverse Event Report: LITECURE, LLC LIGHTFORCE; THERAPY LASER

Model Number	LTC-1500
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Radiation Burn (1755)
Date of Event	12/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product malfunction suspected.Device being returned for evaluation to confirm.Supplemental report will be issued when evaluation completed.
Event or Problem Description
Patient developed blister on foot that may have been contributed to by the subject device.

• Brand Name: LIGHTFORCE
• Common Device Name: THERAPY LASER
• Manufacturer (Section D): LITECURE, LLC; 101 lukens drive; suite a; new castle DE 19720 2791
• MDR Report Key: 8437489
• Report Number: 3006268867-2019-00002
• Device Sequence Number: 19390095
• Product Code: ILY
• UDI-Device Identifier: 00854103007042
• UDI-Public: (01)00854103007042(11)180328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LTC-1500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR