inforMED
InjuryILY

LIGHTFORCE

Received Mar 20, 2019 · Event occurred Dec 14, 2018

Report 3006268867-2019-00002 · MDR key 8437489

Device

Generic name

Therapy Laser

Manufacturer

Litecure, Llc

Model number

LTC-1500

Product problems

  • Improper or Incorrect Procedure or Method
  • Improper or Incorrect Procedure or Method

Patient

45 YR

  • Radiation Burn
  • Radiation Burn

Narrative

Additional Manufacturer Narrative

NO PRODUCT MALFUNCTION SUSPECTED. DEVICE BEING RETURNED FOR EVALUATION TO CONFIRM. SUPPLEMENTAL REPORT WILL BE ISSUED WHEN EVALUATION COMPLETED.

Description of Event or Problem

PATIENT DEVELOPED BLISTER ON FOOT THAT MAY HAVE BEEN CONTRIBUTED TO BY THE SUBJECT DEVICE.