MAUDE Adverse Event Report: LUMENIS BE LTD ULTRAPULSE CO2 LASER WITH ACTIVE FX AND DEEP FX HEADS; POWERED LASER SURGICAL INSTRUMENT

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930); Itching Sensation (1943); Scar Tissue (2060); Impaired Healing (2378); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 02/08/2021

Event Type  Injury  

Event Description

(b)(6) did the ultrapulse active fx & deep fx co2 laser on my back & face for acne scars, causing hypertrophic burn scars over my face.I told him i formed hypertrophic scars after 6 rf microneedling sessions that year.He told me co2 laser is the "gold standard" to treat these, but history of iatrogenic scars is a contraindication.He never gave me a test spot, which lumenis instructs.He said co2 laser is a different modality & wouldn't interact with my rfm sessions ending 1 month prior, so i didn't need to wait.He didn't determine my skin type (fitzpatrick 3) or inform me on adverse events related to being darker than lumenis advises.He didn't give me skin preparation protocol to reduce chance of complication, which lumenis instructs.He said my blood disease, heterozygous hemoglobin lepore, didn't matter with respect to co2 laser.However, hemoglobin abnormality can predispose one to infection & prevent normal healing.I first tried co2 laser on my back since he never gave me a test spot.There was no pre-op appointment.I was not tested for pulmonary tb given my latent tb.Neither was i given a sars-cov-2 test.There was no antimicrobial prophylaxis.The only instruction was keep the area moist.He never informed me of risks like infection.There was no followup or emergency contact info given.Nobody ever checked up after.He didn't show me boundaries he would treat in.No eye protection was given.I was told to come back 1 month post.After, i expressed concern over how long redness lasted, but he told me it was for sure a good sign.The treatment on my back left me with permanent laser gridding.I next did what he said was the same procedure on my face.There was a pre-op call with a nurse.She gave me a 10-day supply of doxycycline & valtrex 2x/day, to start 1 day pre-procedure.I voiced concern over doxycycline because i did it 3 times for acne & it stopped working, but she said i was wrong.I also told her i was currently on sarecycline, another tetracycline, for the past 1.5 years & had previously done minocycline too, which i also felt i was resistant to.No susceptibility testing was offered, despite having active acne.Doxycycline is not in one of the antibiotic classes typically prescribed for co2 laser.Tetracyclines are contraindicated for co2 laser due to photosensitization.On the day of the co2 laser on my face, nurses gave me percocet & valium.They made me sign a consent form after the drugs kicked in, under duress, denying my right to informed consent.Dr.(b)(6) said my active acne cysts were safe & lasered over them.However, active infection is a contraindication.He made no markings.Nurses told me it would be mild.The next morning, dr.(b)(6) told me he used the most intense settings.The only instructions he gave me were do vinegar soaks until scabs came off & apply vanicream.I later realized he did full ablation even though he told me it would be fractional, the same as he did on my back.Medical records were inaccurate (e.G., deep fx spot size recorded as 10mm).He did not respond to request to clarify.I did not hear him preview laser patterns or check alignment as lumenis instructs.His aim was poor.No corneal shields, just goggles, were given.No skin cooling was given aside from what the device provides.He went too deep on the mandible, which is prone to scarring.He gave me no follow-up after the 1-day followup.When i emailed with concerns like delayed healing, significant redness, irritation, swelling, & induration, he diagnosed everything was fine over email.He prescribed sarecycline & tretinoin for acne-like breakouts without culturing.When i tried to see him for concerns, he delayed appointments by weeks.When i did see him, i showed fever & infection signs he disregarded.He never gave a topical steroid, despite lumenis' instructions.He left me with hypertrophic scars, skin-appendage loss, fat loss, chronic pruritus, elasticity loss, hypopigmentation & hyperpigmentation.Fda safety report id #(b)(4).

Event Description

Additional information received from reporter on 02/07/2023 for mw5113591.Reporter calling, stating he is seeking information on a response from the device manufacturer.Reporter states he has contacted them regarding the adverse events he has experienced and the manufacturer is refusing to share their narrative/response other than to tell him that he should wait for the information to be filed in maude.

• Brand Name: ULTRAPULSE CO2 LASER WITH ACTIVE FX AND DEEP FX HEADS
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS BE LTD
• MDR Report Key: 15906339
• MDR Text Key: 304867226
• Report Number: MW5113591
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 25 YR