FDA Adverse Event Injury Summary report: N

"CO2 LASER"

MDR report key: 15543800 · Received October 4, 2022

Report

Report Number
MW5112445
Event Type
Injury
Date Received
October 4, 2022
Date of Event
January 16, 2022
Report Date
September 30, 2022
Manufacturer
UNK
Product Code
GEX
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

DR (B)(6) PLASTIC SURGEON RUINED MY FACE WITH A CO2 LASER IN (B)(6) 2022. HE REFUSES TO TELL ME WHAT THE NAME OF THE LASER IS CALLED NOR WHY MY FACE IS COMPLETELY DESTROYED; HE TERMINATED OUR MEDICAL RELATIONSHIP WHEN HE SAW WHAT THE LASER DID TO MY FACE MONTHS AFTER I EMAILED/CALLED HIM SAYING IT MADE MY SURGICAL INCISION SEPARATE; HE TOLD ME I WAS OVERREACTING AND HE'S ON VACATION/STOP CALLING HIM BECAUSE NOT MEDICAL EMERGENCY. I HAVE PROOF OF ALL OF THIS AND HAVE SENT IT TO AN ATTORNEY. DR (B)(6) WON'T RELEASE MY MEDICAL RECORDS TO ME AND WHEN I WENT INTO HIS OFFICE SAID IT'S "(B)(6) PER PAGE AND THERE ARE OVER 300 PAGES." I TOLD THEM I WANTED THE FIRST PAGE SO I PAID (B)(6) DOLLARS FOR ONE SHEET; HIS MEDICAL RECORDS ARE FALSIFIED AND SAID I PICKED AT MY FACE? ALSO, NEVER REFUNDED ME MY (B)(6) EVEN THOUGH HE PERMANENTLY DISFIGURED MY FACE. I USED TO MODEL AND I'M ABOUT TO LOSE MY CORPORATE JOB AS WELL SINCE CLIENTS KEEP ASKING ME IN SALES MEETINGS WHAT HAPPENED TO MY FACE. I TRULY HOPE HE NEVER DOES THIS TO ANYONE ELSE WITH THAT LASER. FOR ALL I KNOW HE BURNT MY SKIN OFF. THE QUOTES I RECEIVED FROM OTHER PLASTIC SURGEONS MAKE NOTE OF PERMANENT LASER SCARRING; THEY EVEN ASKED ME IF I'M SURE IT WAS A CO2 LASER. PLEASE GET THIS OFF THE MARKET. DR (B)(6) TOLD ME IT'S CO2 LASER. WON'T TELL ME THE NAME, DR (B)(6) WON'T TELL ME. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1531259 "CO2 LASER" POWERED LASER SURGICAL INSTRUMENT GEX UNK

Patients

Seq Age Sex Outcome Treatment
1 26 YR Female Hospitalization| O| S| R ADDERALL 20MG| DOXYCYCLINE WAS USED AT TIME| VALACYCLOVIR