(INTENSE PULSED LIGHT) TREATMENT

Description of Event or Problem

TO WHOM IT MAY CONCERN, I AM REPORTING AN ADVERSE EVENT RESULTING FROM TREATMENTS ADMINISTERED BY (B)(6), WHICH CAUSED SEVERE PHYSICAL AND EMOTIONAL DAMAGE. THESE TREATMENTS, PERFORMED AT THEIR (B)(6) CLINIC, HAVE LEFT ME WITH PERMANENT SCARRING, DISCOLORATION, PAINFUL ACNE, AND EMOTIONAL DISTRESS. PATIENT DETAILS: (B)(6). INITIAL TREATMENT DATE: (B)(6) 2023. PROVIDER: (B)(6) CLINIC. TREATMENT AND ADVERSE EFFECTS: IPL TREATMENT ((B)(6) 2023): I RECEIVED IPL (INTENSE PULSED LIGHT) TREATMENT TO IMPROVE SKIN APPEARANCE. WITHIN HOURS, I EXPERIENCED SEVERE REDNESS, SWELLING, AND PAIN, WHICH WORSENED OVER TIME. THE SWELLING AND REDNESS PERSISTED, FOLLOWED BY PERMANENT INDENTATIONS, SCARRING, AND DISCOLORATION, WHICH HAVE ALTERED MY FACIAL APPEARANCE. CLEAR AND BRILLIANT PROCEDURE: WHEN IPL WAS DISCONTINUED, I WAS COERCED INTO A CLEAR AND BRILLIANT PROCEDURE, MARKETED AS A CORRECTIVE TREATMENT FOR IPL DAMAGE. INSTEAD, THIS WORSENED MY CONDITION, CREATING DEEPER SCARS AND DISCOLORATION. CURRENT STATUS: THE DAMAGE IS PERMANENT. THE SCARRING IS VISIBLE AND PAINFUL, AND THE DISCOLORATION HAS CAUSED UNEVEN SKIN TONE. THE PHYSICAL DAMAGE CONTINUES TO CAUSE DISCOMFORT, AND I EXPERIENCE SIGNIFICANT EMOTIONAL DISTRESS DUE TO ALTERED APPEARANCE. ATTEMPTS FOR RESOLUTION: REFUND AND CORRECTIVE CARE REQUEST: I REQUESTED A REFUND AND CORRECTIVE CARE FROM (B)(6), BUT MY ATTEMPTS WERE IGNORED. DESPITE FURTHER TREATMENTS THAT WORSENED MY CONDITION, THEY REFUSED TO OFFER A RESOLUTION. HARASSMENT AND RETALIATION: I FILED A COMPLAINT WITH THE (B)(6), WHICH LED TO HARASSMENT FROM (B)(6) REPRESENTATIVES, INCLUDING THREATS OF LAW ENFORCEMENT INVOLVEMENT. HEALTH EFFECTS: PHYSICAL EFFECTS: SEVERE REDNESS, SWELLING, BURNING SENSATION, PERMANENT SCARRING, AND DISCOLORATION. ONGOING PAIN FROM SCARRING. PSYCHOLOGICAL EFFECTS: THE PERMANENT SCARRING HAS CAUSED DEPRESSION, ANXIETY, AND SIGNIFICANT LOSS OF SELF-ESTEEM. OUTCOME: THE PERMANENT PHYSICAL DAMAGE CONTINUES TO AFFECT MY QUALITY OF LIFE. I EXPERIENCE BOTH PHYSICAL PAIN AND EMOTIONAL DISTRESS DUE TO THE DISFIGUREMENT AND THE FAILURE OF (B)(6) TO PROVIDE RESOLUTION. ACTION REQUESTED: I AM REQUESTING THE FDA TO INVESTIGATE THE SAFETY OF IPL AND CLEAR AND BRILLIANT TREATMENTS OFFERED BY (B)(6) AND EVALUATE THEIR BUSINESS PRACTICES TO PREVENT FURTHER HARM TO PATIENTS. SINCERELY, (B)(6). REFERENCE REPORT: MW5163781.