[16593040]
Treated patient with cutera trusculpt as advised by company representative for fat reduction, patient 3 days out had severe swelling, (b)(6) lb weight gain, pain in treated areas, treated again (b)(6) 2013 as advised by sales rep, patient again 3 days out from treatment gained an additional (b)(6) lbs in addition to the (b)(6) lb weight gain from previous tx, severe swelling, pain in treatment area. We were advised by company field rep to wait 4 months from original treatment to have full result. (b)(6) 2013 called (b)(6) at cutera to be advised as what to do, she said give it more time, patient saw our medical director (b)(6) 2014 who used a 16 gauge needle to tap areas. Nothing came out. Medical director feels because of the length of time it's irreversible damage, patient is now seeking opinions from plastic surgeons. Cutera has been made aware of this. We had a conference call with dr (b)(6) and (b)(6) the head clinical nurse. Nothing has been done, no contact has been made to us after many attempts via email and phone to cutera. Cutera has never sent out a representative to evaluate the patient, or to evaluate the machine for any defects. They are not telling how to fix or reverse damage. Their sales reps are selling this as a fat reduction/fat melting device; however, upon further research, they have not studied the effects of fat reduction and how it affects the body/lymphatic system. Patient has had some form of structure damage and cutera is not calling us. They have never reached out to us to ask about the findings.
Patient Sequence No: 1, Text Type: D, B5