FDA Adverse Event Injury Summary report: N

REV-LITE Q SWITCHED LASER

MDR report key: 6493199 · Received April 12, 2017

Report

Report Number
MW5069093
Event Type
Injury
Date Received
April 12, 2017
Date of Event
July 28, 2016
Report Date
April 12, 2017
Manufacturer
CYNOSURE, INC
Product Code
GEX
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NM, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I SUSTAINED A BOTCHED LASER TREATMENT WITH DR (B)(6). REV-LITE Q SWITCHED LASER FOR AESTHETIC PROCEDURE TO FACE. "NO DOWN TIME PROCEDURE" RESULTED IN SECOND DEGREE BURNS TO THE ENTIRE FACE, WITH PERMANENT SCARRING. MY COMPLAINTS/RECOMMENDATIONS ARE AS FOLLOWS: THERE SHOULD BE HIGHER QUALIFICATIONS SET FORTH FOR THE OPERATORS OF SUCH COSMETIC LASER DEVICES. OFTEN A WEEKEND WORKSHOP IS ALL THAT IS NEEDED TO QUALIFY A PRACTITIONER OF LITTLE TO NO EXPERIENCE. THESE DEVICES ARE TOO RISKY AND THE HARMFUL EFFECTS CAN BE DEVASTATING TO PATIENTS WHEN THEY DO NOT ALL TOO UNCOMMONLY GO WRONG. THERE SHOULD BE A CLEAR DISCLOSURE OF THE ACTUAL AND POTENTIAL RISKS LAID OUT FOR PATIENTS WHO ARE UNDERGOING THESE PROCEDURES. PATIENTS SHOULD BE PRESENTED WITH ALL POSSIBLE OPTIONS FOR ACHIEVING THEIR AESTHETIC GOALS, NOT SIMPLY DIRECTED TO LASERS FIRST. OFTEN LASER TREATMENT IS PRESENTED BECAUSE MEDICAL PRACTITIONERS ARE PAYING OFF THEIR DEVICES AND/OR LASERS PRESENT THE BEST FINANCIAL MEANS FOR THE PRACTITIONERS; AND NOT BECAUSE LASER IS IN THE BEST INTEREST OF THE PATIENT. THERE ARE OTHER, LESS RISKY AESTHETIC PROCEDURES, SUCH AS MICRONEEDLING, WHICH CAN ACHIEVE THE DESIRED RESULT WITH MUCH LESS RISK. WHEN A MEDICAL PRACTITIONER DOES BOTCH A LASER TREATMENT, WHETHER THEY ACKNOWLEDGE MALFUNCTION OR NOT, THERE SHOULD BE AN ETHICAL PROTOCOL OF CARE IN WHICH THE PRACTITIONER SHOULD BE RESPONSIBLE FOR HELPING THE PATIENT HEAL AND RESTORE THE AESTHETICS OF THEIR SKIN. MORE LASER TREATMENT IS NOT A VALID MEANS FOR HEALING LASER DAMAGED SKIN. OTHER THAN AN INSISTENCE ON MORE LASER TREATMENT AND AN UNWILLINGNESS TO HELP ME IF I DID NOT ACCEPT MORE LASER TREATMENT, I RECEIVED NEARLY NO SUPPORT FROM DR (B)(6) IN HEALING MY LASER DAMAGED SKIN. ONLY A FOOL WOULD ACCEPT MORE LASER TREATMENT TO CORRECT SECOND DEGREE LASER BURNS AND SCARS. DR (B)(6) IS A PEDIATRICIAN WHO OFFERS SKIN LASERING ON THE SIDE AND DOES NOT KNOW WHAT SHE IS DOING. HER ETHICS AROUND HELPING ME HAVE BEEN DEPLORABLE AND THE HEALING PROCESS HAS COST ME TENS OF THOUSANDS OF DOLLARS. ALTHOUGH THERE ARE PLENTY OF SATISFIED LASER CUSTOMERS OUT THERE, THE PERCENTAGE OF FAILURE IS TOO HIGH. SOME PEOPLE WIND UP DEEPLY DEPRESSED AND SUICIDAL OVER THESE BOTCHED TREATMENTS. MANY DO NOT HAVE THE FINANCIAL MEANS TO PAY FOR THE MEDICAL ATTENTION NEEDED TO RESTORE THEIR FACES. THE MEDICAL ESTABLISHMENT CONTINUES TO MAKE MORE MONEY, WELL BECAUSE MONEY IS THE NAME OF THE GAME, RIGHT? WRONG. WHAT ABOUT THE DOCTORS OATH TO "DO NO HARM?" THE NEGLIGENCE IN THESE SITUATIONS IS RAMPANT AND THE MEANS TO WIN A LAW SUIT IN SUCH CASES IS NOT SET UP FOR PATIENT JUSTICE. THE LEGAL SYSTEM IS DESIGNED TO PROTECT THE DOCTORS. I STRONGLY REQUEST THAT THE RATE OF FAILURE AND THE DEVASTATING EFFECTS OF BOTCHED LASER TREATMENTS BE REVIEWED AND EVALUATED BY THE FDA, WITH MUCH STRONGER CONTROLS AND PROTOCOL OF CARE SET FORTH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
269839 REV-LITE Q SWITCHED LASER POWERED LASER SURGICAL INSTRUMENT GEX CYNOSURE, INC

Patients

Seq Age Sex Outcome Treatment
1 47 YR Required Intervention