FDA Adverse Event Other Summary report: N

LASERSCOPE

MDR report key: 704246 · Received April 12, 2006

Report

Report Number
MW1038608
Event Type
Other
Date Received
April 12, 2006
Date of Event
December 30, 2005
Report Date
April 12, 2006
Manufacturer
LYRA
Product Code
GEX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD LASER HAIR REMOVAL DONE ONCE FOR MY UNIBROW BY MD. I USED THE TOPICAL ANESTHETIC NUMBING CREAM AND SHAVED THE AREA TO BE LASERED. AFTER THE PROCEDURE I GOT REALLY SWOLLEN AND THE SKIN GOT HARDENED AND I GOT BLISTERED REALLY BAD. DR GAVE ME "FOUGERA BETAMETHASONE VALERATE CREAM" TO APPLY THERE AND SAID WHEN I GET HOME TO PUT ICE ON IT. WHEN I GOT HOME I NOTICED A LOT OF FLUIDS COMING FROM THE AREA. THIS WAS DONE ON A SATURDAY AND DR WOULDN'T BE BACK IN UNTIL THE MONDAY COMING UP, AS HE SAID TO CALL HIM IF I HAVE ANY PROBLEMS SO HE COULD GIVE ME SOMETHING. I THEN CALLED DR TO PRESCRIBE ME SOMETHING BUT WOULDN'T UNLESS I CAME IN BUT AT THIS POINT I WAS REALLY LOOKING BAD AND COULDN'T LEAVE MY HOME. I HAD MAJOR SWELLING FOR MORE THAN A WEEK. DR SAID HE WOULD HAVE GIVEN ME ANTIBIOTICS FOR INFECTION BUT THE DAMAGE WAS ALREADY DONE AND I SCABBED AND GOT SCARRING. I HAD A FOLLOW UP TO SEE DR FOR HELP AND HE SAID THAT HE WOULDN'T PAY FOR ME SEEKING HELP TO HELP FIGURE AND FIX THE PROBLEM ASIDE FROM DOING LASER WITH THE "AREA" TO GET RID OF THE COLOR OF THE SCAR BUT AT THIS POINT I DIDN'T WANT ANYMORE LASER DONE BY HIM. I FEEL I GOT BURNED BY THE LASER OR DR PERFORMED THE PROCEDURE WRONG. HE USED THE LYRA LASERSCOPE I BELIEVE. I HAVE COSMETIC DAMAGE ON MY FACE AND I AM REALLY UNHAPPY AND HURT. KEEP IN MIND THAT I ONLY HAD THE LASER HAIR REMOVAL DONE ONCE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LASERSCOPE LASER GEX LYRA * *

Patients

Seq Age Sex Outcome Treatment
1 28 YR Other