inforMED
InjuryOLI

ZERONA

Received Mar 5, 2020 · Event occurred Jan 21, 2020

Report MW5093577 · MDR key 9800735

Device

Generic name

Fat Reducing Low Level Laser

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

41 YR

  • Cancer
  • Cancer

Narrative

Description of Event or Problem

CANCER; I RECEIVED ZERONA THERAPY (MAKES HOLES IN FAT CELLS) IN ONE PARTICULAR AREA UNDER MY ARM PIT / NEAR MY BREAST IN 2014 AND NOW 6 YEARS LATER I HAVE BREAST CANCER IN THAT EXACT SAME LOCATION (I'M (B)(6) Y/O) AND FEEL THERE IS A LINK AS I HAVE NO FAMILY HISTORY. FDA SAFETY REPORT ID# (B)(4).