FDA Adverse Event Injury Summary report: N

LUMENIS M22

MDR report key: 3453097 · Received October 30, 2013

Report

Report Number
MW5032510
Event Type
Injury
Date Received
October 30, 2013
Date of Event
October 10, 2013
Report Date
October 29, 2013
Manufacturer
LUMENIS AESTHETIC
Product Code
GEX
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2013, I HAD AN INTENSE PULSE LIGHT TREATMENT AT A MEDICAL SPA. IT IS ADVERTISED AS A LUNCH TIME PROCEDURE WITH NO DOWN TIME. MY INTENT WAS TO DIMINISH A BROWN SPOT ON MY CHEEK AD A FEW BROKEN CAPILLARIES NEAR MY NOSE. I HAVE FAIR SKIN, DO NOT TAN, AND I DO NOT USE RETIN-A PRODUCTS. THE MACHINE WAS A LUMENIS M22 WITH SETTINGS OF 560NM AND 19 JOULES (SUPPOSEDLY CONSERVATIVE SETTINGS). I HAVE NEVER HAD A LASER TREATMENT OR IPL BEFORE. I WAS AN INTENSE RED FOR ABOUT 48 HOURS AND IT FELT LIKE A SUNBURN. THE REDNESS DIMMED TO A PINK COLOR, BUT MY FACE STILL FELT VERY WARM TO THE TOUCH I THEN DEVELOPED TINY BUMPS ALL OVER MY FACE AND AN ORANGE PEEL TEXTURE. I WENT TO MY DERMATOLOGIST AND SHE DIAGNOSED ME MY VERY FIRST CASE OF ROSACEA. I WAS PRESCRIBED METROGEL AND ANTIBIOTICS, WHICH HELPED. WHEN I WOKE UP ON THE MORNING OF (B)(6), I NOTICED LARGE DEPRESSED AREAS UNDER BOTH CHEEKBONES AND ON MY FOREHEAD. MY FOREHEAD DEVELOPED A RIDGE AS IF THE FAT UNDER THE SKIN HAD PARTIALLY MELTED OFF. MY SKIN IS EXHIBITING PITTING, SCARS, AND TEXTURE PROBLEMS THAT WAS NEVER THERE BEFORE. THE OUTLINE OF THE ILP MACHINE'S WAND CAN BE SEEN IN SOME PLACES. MY DERMATOLOGIST DIAGNOSED IT AS FAT NECROSIS/SKIN ATROPHY. I HAVE LINES ALL OVER MY FACE AND MY UPPER LIP SEEMS TO BE DISAPPEARING. I HAVE NEVER SMOKED, BUT NOW I HAVE FINE PUCKERED LINES ABOVE MY UPPER LIP. MY DERMATOLOGIST SAID SOMETHING WENT WRONG WITH THE IPL; IT WAS EITHER A MACHINE OR OPERATOR ERROR. SHE CONFIRMED THAT THE SETTINGS USED (I OBTAINED MY RECORDS FROM THE MED SPA) WERE CONSERVATIVE. I SPOKE WITH THE DOCTOR THAT RUNS THE MEDICAL SPA; HE SAID THAT THE LUMENIS M22 IS A SELF-CALIBRATING MACHINE. I HAVE PERMANENT DAMAGE TO MY SKIN, WHICH IS BOTH PHYSICALLY AND PSYCHOLOGICALLY DIFFICULT. ALTHOUGH THERE HAS BEEN SOME IMPROVEMENT DUE TO A ROUND OF PREDNISONE, I AM CONTINUING TO EXPERIENCE SYMPTOMS. I DISCOVERED A (B)(4) STUDY INDICATING THAT INTENSE PULSE LIGHT CAUSES OXIDATIVE STRESS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
557395 LUMENIS M22 LUMENIS M22 GEX LUMENIS AESTHETIC UNKNOWN TO ME UNKNOWN TO ME

Patients

Seq Age Sex Outcome Treatment
1 51 YR Required Intervention| S