Description of Event or Problem · 1
THE (B)(6) LASER CLINIC LIMITED ((B)(6)) PURCHASED 6 GRADE 4 LASERS DESIGNED BY THE MANUFACTURER REFERRED TO IN THIS DOCUMENT VIA ITS (B)(4) DISTRIBUTOR. ON THIS OCCASION (AND THERE WERE OTHERS) ONE OF THE LASERS CAUSED SERIOUS AND SIGNIFICANT BURNS TO THE BACK OF THE PATIENT ((B)(6)). (B)(6) HAS SUCCESSFULLY SUED THE (B)(4) DISTRIBUTOR IN THE HIGH COURT IN (B)(6) AND WAS, ON (B)(6) 2019, AWARDED DAMAGES OF THE GBP EQUIVALENT OF (B)(6) PLUS COSTS FOR CLAIMS/WARRANTIES MADE BY THE DISTRIBUTOR. (B)(6) NOW WISHES TO NOTIFY THE FDA OF THE MATERIAL AND MAJOR SAFETY ISSUES ASSOCIATED WITH THESE LASERS AND THE CLAIMS MADE (AND CONTINUE TO BE MADE) BY THE MANUFACTURER AS THESE MACHINES CAN CAUSE SERIOUS AND PERMANENT INJURY TO INDIVIDUALS. MAGMA LASER (510K REF K 153566). FDA SAFETY REPORT ID # (B)(4).