MAUDE Adverse Event Report: INMODE LTD MORPHEUS 8 MICRONEEDLING AND RF/ RADIOFREQUENCY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330)

Event Date 09/14/2020

Event Type  Injury  

Event Description

A painful procedure called morpheus8 micro needling rf (radio frequency) was performed on me at (b)(6) plastic surgery in (b)(6) and not by a medical doctor, but an "aesthetician" on (b)(6).I kept telling the girl it hurt, and she said it was normal and kept playing with the machine settings.She went over a large area of my neck, under the chin, jawline, and just below the collarbone for 3 rounds.It is now (b)(6) and i still have tremendous "track marks" and raised fat "bumps" under the skin that looks likes alligator skin texture or orange peel, it's red, painful, disgusting, highly noticeable, and also my glands under my chin hurt and i have nerve pain in my jaw.I have permanent skin damage, permanent change in texture, scarring, hyperpigmentation, and pain that comes and goes.The plastic surgery office is calling my reaction "too emotional" and stress-induced because of the pandemic, but i believe they are avoiding the issue of the mechanical injury.Additionally, i went to speak to them 7 days later, with a red, inflamed, damaged neck, and a physician was there and didn't even want to see me, they instead provided a technician to speak with me.I was terrified and in pain, and so then went to see a dermatologist (a real md) who is knowledgeable in micro needling and he said that it is not my fault that i trusted the (b)(6), and my skin is indeed marked and terribly inflamed and painful.The dermatologist feels this is an atypical reaction, and cannot explain why.No one knows what to do to get my old skin's normal texture back.He has me on antibiotics, (b)(6) ointment only, and naproxen for the pain.In contrast, the plastic surgery team is only worried about themselves, they have not been caring or helpful and are only "going through the motions" and blaming the patient, by saying i am emotional.However, most patients do not have these post-procedure complications that are this long-lasting, as it's usually gone within a week.My procedure was done on (b)(6), and it's now (b)(6) and i'm still suffering pain and discomfort and have visible, disgusting skin texture that looks like a reptile.They hurt me.That machine is dangerous and should be banned by the fda.This has been extremely traumatic, and the physical and emotional damage will be permanent and i will never be able to trust physicians easily again, and will never trust these other "aestheticians" or even the nurses.Fda safety report id# (b)(4).

• Brand Name: MORPHEUS 8 MICRONEEDLING AND RF/ RADIOFREQUENCY
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD
• MDR Report Key: 10634541
• MDR Text Key: 210244701
• Report Number: MW5097090
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 98 YR