inforMED
InjuryKCW

NO NO HAIR

Received Oct 10, 2015

Report MW5057160 · MDR key 5161585

Device

Generic name

Hair Removal Device

Product problems

  • Therapeutic or Diagnostic Output Failure

Patient

75 YR

  • Scarring

Narrative

Description of Event or Problem

THE NO-NO HAIR DEVICE LEFT LITTLE BROWN DOTS ON MY LEGS AND DID NOT REMOVE MUCH HAIR. I CALLED THE COMPANY FOR A REFUND BUT HAD BEEN AWAY ON VACATION AND THE TRIAL PERIOD HAD EXPIRED. I RETURNED IT AND THEY SENT ME A NEW ONE. IT DID REMOVE SOME OF THE HAIR ON MY LEGS BUT NOT AS ADVERTISED AND AGAIN MORE BROWN DOTS ON MY LEGS. I DID NOT USE IT ON MY FACE AS I DID NOT WANT TO BE COVERED WITH BROWN DOTS. WAS THIS DEVICE APPROVED BY THE FDA? WHEN I ASKED TO SPEAK TO A SUPERVISOR HE WAS VERY RUDE. I DID NOT SEE A PHYSICIAN OR HAVE ANY LAB TESTS. DATES OF USE; 1 MONTH. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED; YES. EVENT REAPPEARED AFTER REINTRODUCTION; YES.