This complaint was initially reported by the patient directly to fda on 04-jan-2023 (mw5114225) and stated: "i received a morpheus 8 micro needling treatment on my face which resulted in unwanted permanent fat loss, changes in my face structure, indentations in my face which will require surgical repair.I also experienced severe head pain and had a brain mri following the treatment.".
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This complaint was initially reported by the patient directly to fda on 04-jan-2023 (mw5114225) and stated: "i received a morpheus 8 micro needling treatment on my face which resulted in unwanted permanent fat loss, changes in my face structure, indentations in my face which will require surgical repair.I also experienced severe head pain and had a brain mri following the treatment.".
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Based on the information provided by the treatment provider, event date was corrected to 2022, and not 2021 as initially reported by the patient to fda.This means that the patient reported the alleged adverse events to fda 1 year post treatment, and not 2 years.The treatment date was also confirmed by patient's posts on a social network.Inmode performed investigation and the reported adverse events could not be confirmed.The event was downgraded to non serious.Five months post tx the patient complained to the provider about fat loss under her eyes, but on the fu visit the provider actually noted reduction of fine lines under her eyes and documented "skin looked great".This indeed is seen on the provided photos.Later, patient received botox injections, which affected the eyebrows position, as confirmed by the treatment provider.Treatment settings with morpheus8 in the periorbital area were not aggressive and were within the recommended limits.Eight months post tx the provider could not detect the alleged problem.Regarding head pain that the patient reported in her complaint to fda: she posted later on social network "my brain mri came back normal".To conclude, the alleged adverse events could not be corroborated neither by the photos, nor by the treatment provider.
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