HIFU ULTRASOUND MACHINE WITH AN ARRAY TRANSDUCER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-10 for HIFU ULTRASOUND MACHINE WITH AN ARRAY TRANSDUCER manufactured by Unk.

Event Text Entries

[133377100] After receiving flyer through the mail for (b)(6) in (b)(6), i made an appt for a consultation for a "cosmetic" procedure and agreed to an ultrasound, as i assumed it was protocol. Before seeing any dr, i filled out some of my paperwork that would indicate whether i was a good candidate for surgery, but i did not complete my vein symptoms sheet. Despite having no varicosities or debilitating symptom's, i was given a leg ultrasound by(b)(6), that focused on my groin and pelvic region. Ultrasound are not supposed to hurt but this leg ultrasound caused inordinate bursts of horrific pain when applied to my groin region, (sapheno femoral junction, specifical), and other tender areas in my pelvic region. These piercing pain sensations emanating from the sonographer's probe were felt a minimum of 4 times on each leg, after the tech "oscillated" his transducer probe. After the ultrasound a nurse's aide asked me to sign a legal waiver and told me my vein valves were damaged. They wanted to sign a treatment plan for removal of my grand saphenous veins from the groin to the soles of my feet. Dr (b)(6), the interventional diagnostic radiologist who performs the vein ablations popped into the room for 5 mins wanting to know if i had any questions about the procedure. He never bothered to look at or examine my legs. Still in a bit of shock from the strange ultrasound, i had enough wits to conclude that my lack of symptoms and cosmetic reasons for going there in the first place did not warrant the over diagnosis. I came to the conclusion that these people were unethical charlatans and left. One month after their ultrasound, a kafka-esque transformation took place in my circulatory system and anatomy: thighs swelled, urine burned; there was pain in the groin and in the saphenofemoral junction; heat pain that ran down the length of my legs when standing, inability to sit without pain in vulvar region and glutes, swollen pelvis and abdominal pain, heat coming from all these areas including my kidneys, part of my head, a changed gait. I phoned the (b)(6) center to report that the ultrasound tech mutilated my vein valves in my groin and pelvic region, that i couldn't cross my legs or sit without pain, my underwear no longer fit. I thought i was bleeding internally and strangely, no pain. Dr (b)(6) told me to go to the emergency room but to come to the vein clinic for another leg ultrasound. Of course i said no. Dr (b)(6) then wrote and published on an online database my medical records, which he prepared after the fact, describing my symptoms from the ultrasound as if those were the symptoms i went to the (b)(6) clinic for - symptoms i have never had or claimed to have prior to getting an ultrasound at the (b)(6) in (b)(6). I went in for a 'cosmetic' consult for spider veins. Seven months have gone by and i'm having difficulty functioning and rectifying the situation. One of the problems is that images provided by cat scans or doppler leg ultrasounds done at hospitals don't meet diagnostic criteria for venous insufficiency, and i am told to go to a pain mgmt center. Utterly frustrated and exhausted. I began last week to research how a simple ultrasound could have hurt me so much. I came across an online class on high intensity focused ultrasound and enrolled in it. I learned about this therapeutic technology that necrotized tissue; that is not fda approved for venous ablation but there are clinical trials going on. Having recalled the old fashioned looking machine at the center for vein restoration and the way the sonographer there oscillated his probe before i felt piercing hot pain. I knew that he had used hifu on me - and without my informed consent. They are using hifu at the (b)(6) in (b)(6) to destroy otherwise healthy vein valves thus inducing pain and venous insufficiency.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083076
MDR Report Key8239935
Date Received2019-01-10
Date of Report2019-01-08
Date of Event2018-05-29
Date Added to Maude2019-01-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameHIFU ULTRASOUND MACHINE WITH AN ARRAY TRANSDUCER
Generic NameTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Product CodeNRZ
Date Received2019-01-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 1

Brand NameHIFU ULTRASOUND MACHINE WITH AN ARRAY TRANSDUCER
Generic NameTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Product CodeITX
Date Received2019-01-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention; 2. Deathisabilit 2019-01-10

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