FDA Adverse Event Injury Summary report: N

ISOLAZ LIGHT THERAPY AESTHERA COMPANY SOLTA MEDICAL INC. LAZER TREATMENT

MDR report key: 2536402 · Received April 10, 2012

Report

Report Number
MW5024995
Event Type
Injury
Date Received
April 10, 2012
Date of Event
July 23, 2008
Report Date
April 3, 2012
Manufacturer
SOLARA/AESTHERA /ISOLAZ NUD INC
Product Code
GEX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD SIGNED UP WITH DR (B)(6) AT (B)(6) IN (B)(6) 2008, FOR LASER HAIR REMOVAL: I HAD THE ISOLAZ MACHINE USED ON ME (B)(6) 2008 AND HAD TERRIBLE FACIAL SCARRING LESION, STARTED AFTER THE SESSION. I RETURNED TO SEE DOCTOR SEVERAL TIMES AFTER INCIDENT. TOLD THAT AROUND A YEAR LATER, AT FOLLOW UP VISIT, THAT IT WAS AN ELECTRICAL BOARD MALFUNCTION THAT CAUSED MY HIGH INTENSITY BURNS, PAIN, SCARRING THAT REMAINS OVER 6 WEEKS. I HAVE A SMALL, FEW, 2 MARKS LEFT FROM INCIDENT. DR (B)(6) HAD CONTACTED ISOLAZ, HE STATED, THAT DAY AND ASKED WHY THAT WOULD HAVE HAPPENED. ISOLAZ LATER CHECKED ELECTRICAL BOARD AND FOUND TO BE FAULTY. IT HAD ACTUALLY GIVEN ME A DOUBLE DOSE OF ELECTRICAL IMPULSES: IT WAS VERY PAINFUL, AS YOU CAN SEE, SCARRING WAS TREMENDOUS POST TREATMENT. DOUBLE ELECTRICAL IMPULSE GIVEN ON TREATMENT (B)(6) 2008. BY ISOLAZ MACHINE AFTER DR. (B)(6) HAD IT CHECKED. SEVERE PAIN, BURNING IMPULSE ON CONTACT WITH ISOLAZ MACHINE TREATMENT LESIONS STARTED THAT DAY WITHIN TIME I LEFT OFFICE. THEY WANTED ME TO USE REAR DOOR TO LEAVE SO NO ONE SEE ME. DR. (B)(6) WANTED ME BACK NEXT DAY (B)(6) 2008 AND THEN ON TO MONITOR LESIONS AND TRY TO TREAT THEM WITH OTHER METHODS NOT ISOLAZ. AROUND (B)(6) 2009 HE CONTACTED ISOLAZ THAT DAY OF OCCURRENCE TO DOCUMENT FINDINGS. THROUGH (B)(6) 2009, HAD FACIAL TREATMENT TO CORRECT SCARS OVER COURSE OF NEXT YEAR WITH DR (B)(6) AT HIS OFFICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ISOLAZ LIGHT THERAPY AESTHERA COMPANY SOLTA MEDICAL INC. LAZER TREATMENT ISOLAZ LAZER THERAPY GEX SOLARA/AESTHERA /ISOLAZ NUD INC

Patients

Seq Age Sex Outcome Treatment
1 44 YR Required Intervention| S