inforMED
InjuryOLI

LASER-LIPO (ADVERTISED AS "FDA APPROVED")

Received Nov 22, 2017 · Event occurred Aug 2, 2017

Report MW5073524 · MDR key 7052430

Device

Generic name

Unk

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

60 YR

  • Hemorrhage/Blood Loss/Bleeding
  • Hematuria
  • Hemorrhage/Blood Loss/Bleeding
  • Hematuria

Narrative

Description of Event or Problem

SPA PERSON PLACED LASER DEVICES USING CLOTH STRAPS FOR A TREATMENT STORAGE BAG FOR URINE CATHETER FULLY OF BLOOD URINE. WENT TO A 7E FIT SPA FOR "FDA APPROVED LASER-LIPO WITH 6 LASERS STRAPPED TO MY ABDOMEN. THAT NIGHT MY CATHETER WIRE STORAGE BAG WAS FULL OF BLOOD. PHOTO ENCLOSED. ALSO SPA COUPON ENCLOSED. BLOOD IN URINE. PROCEDURE PERFORMED AT 7E FIT SPA (SEE ATTACHED COUPON).