LIGHTFORCE

Additional Manufacturer Narrative

A PET OWNER REPORTED AN ADVERSE EVENT TO THE HOSPITAL AFTER GETTING LASER TREATMENT FROM (B)(6) HOSPITAL. THE PET'S OWNER REPORTED THAT THE LASER TREATMENT LED THE DOG TO BE HURT AND BRUTALLY BURNT, WITH SKIN IS SLOUGHING OFF. NO FURTHER INFORMATION WAS RECEIVED. AN ADVERSE EVENT QUESTIONNAIRE WAS SENT TO (B)(6) HOSPITAL BUT HAS NOT BEEN RETURNED, DEVICE NOT RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF NEW INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

A PET OWNER REPORTED AN ADVERSE EVENT AFTER GETTING LASER TREATMENT FROM (B)(6) HOSPITAL. THE PET'S OWNER REPORTED THAT THE LASER TREATMENT LED THE DOG TO BE HURT AND BRUTALLY BURNT, WITH SKIN IS SLOUGHING OFF.