FDA Adverse Event Injury Summary report: N

GENTLEMAX PRO

MDR report key: 3906281 · Received June 30, 2014

Report

Report Number
MW5036939
Event Type
Injury
Date Received
June 30, 2014
Date of Event
June 20, 2014
Report Date
June 30, 2014
Manufacturer
CANDELA CORP
Product Code
GEX
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
DC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2014 I HAD A 5:00PM APPOINTMENT FOR LASER HAIR REMOVAL TREATMENT (LEGS) AT (B)(6). THIS WAS MY FOURTH TREATMENT. I PREVIOUSLY HAD THREE TREATMENTS DONE BY (B)(6). THIS WAS THE FIRST TREATMENT PROVIDED BY (B)(6). USUALLY THE PRACTITIONER ASKS IF THERE WAS A CHANGE TO ANY MEDICATION OR IF I HAVE BEEN EXPOSED TO THE SUN. THIS TIME THE PRACTITIONER DID NOT ASK IF I HAD BEEN EXPOSED TO THE SUN. EVEN THOUGH, I WAS NOT ASKED I EXPLAINED TO THE PRACTITIONER THAT I HAD BEEN EXPOSED TO THE SUN APPROXIMATELY 3 WEEKS PRIOR TO MY APPOINTMENT ON FRIDAY ((B)(6) 2014). THE PRACTITIONER TOLD ME THAT THEY PREFERRED 4 WEEKS BUT I SHOULD BE FINE. I ADDED THAT I THOUGHT THAT IT WAS TWO WEEKS AND ASKED IF THE TREATMENT WOULD BE DELAYED. THE PRACTITIONER SAID NO EVEN THOUGH THEY PREFERRED 4 WEEKS, THREE WEEKS WAS CLOSE ENOUGH, AND I WOULD BE FINE. DURING TREATMENT I COMPLAINED THAT IT WAS VERY PAINFUL, AND I DIDN'T HAVE THAT EXPERIENCE IN THE PAST. SHE SAID WELL IT'S PROBABLY BECAUSE YOU WERE OUT ON THE SUN 3 WEEKS AGO AND IT WOULD BE OVER QUICK. THE PRACTITIONER WOULD HOLD MY LEG DOWN AND PERFORM THE TREATMENT FAST WHILE I WAS COMPLAINING. SHE CONTINUOUSLY KEPT SAYING "OO, I KNOW I KNOW, ALMOST DONE. I KNOW I KNOW IT HURTS, ALMOST THERE". AFTER THE TREATMENT I ASKED HER HOW LONG SHE SAID SHE HAD BEEN DOING THIS AND SHE SAID "3 MONTHS BUT I AM A NURSE PRACTITIONER" I SAID OK. DID YOU CHANGE MY SETTINGS BECAUSE THAT WAS VERY PAINFUL, AND I HAD NOT EXPERIENCED THAT DURING MY LAST THREE TREATMENTS. SHE SAID "NO I USED THE SAME SETTINGS, IT'S PROBABLY BECAUSE YOU WERE EXPOSED TO THE SUN THREE WEEKS AGO". AFTER I WENT HOME I NOTICED MY LEGS WERE SO BURNED, I COULDN'T EVEN SIT DOWN. I WENT TO THE URGENT CARE ON (B)(6) 2014. THIS OCCURRED AT (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
380218 GENTLEMAX PRO GENTLEMAX PRO GEX CANDELA CORP

Patients

Seq Age Sex Outcome Treatment
1 27 YR Required Intervention