SONABLATE 500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for SONABLATE 500 manufactured by Sonacare Medical.

Event Text Entries

[72882477] A medical story about hifu; i was a college professor (phd in mathematics) and afterwards a programmer at (b)(6) for 10 years. I herein submit a shortened version of a medical story. I write this narrative not to register a complaint, but because i hold fast to the chance that someone, by the reading of my fate, might be spared some measure of suffering and grief. In (b)(6) 2007, i underwent a hifu procedure in an attempt to alleviate urinary problems caused by a benign, enlarged prostate. Dr. (b)(6), accompanied by dr (b)(6), carried out the procedure in (b)(6) using the sonablate 500 system designed by ushifu (now sonacare medical) of (b)(4). These were the immediate results: inaccessible catheter entry from the urethra into the bladder prolapsed pelvic floor - irreversible bulges in the rectal wall - irreversible pudendal nerve damage - irreversible lymph system obstruction - irreversible urethral scarring - recurrent after removal. Added to those horrors, a few months later, the original prostate symptoms returned. The pelvic traumas impede and distort the body's ability to store and eliminate solid and liquid waste - painful, destructive, and gruesome. A colo-rectal surgeon put forward that colostomy was the only way to bypass the pelvic and rectal damages. Twice i had the urethral scarring surgically removed. Each time the scarring returned. A local urologist advised that open reconstruction might be necessary to repair the urethra. A vascular surgeon prescribed compression stockings - to manage swelling in the lower extremities brought on by the lymph obstruction - and later an anti-coagulant - to manage a blood clot that had developed. Both the swelling and clot will be everlasting. My encounter with hifu has permanently impaired my health. The hifu experience has saddled me with agonizing disabilities. It has deformed my legs. It has increased the likelihood of blood clots. It has obligated me to be at all times within short range of a bathtub with a nearby toilet. It has ruined my life, turning it into a torturous ordeal. Hifu damages mandate abnormal exertions for waste elimination, contortions which put pressure on my spine and injure healthy tissue. All disorders have worsened with time. All of them generate enormous stress;and all of them distort peacefulness, sleep, and normal living - day and night. I have spent tens of thousands of dollars over the years undergoing medical examinations, tests, and procedures to find relief from the agony and havoc that hifu had wrought. No relief has been forthcoming. Shortly after a (b)(6) 2012 mri substantiated multiple pelvic injuries, i wrote to each of the orchestrators of the hifu procedure/fiasco (dr (b)(6), and ushifu) asking for an explanation of what went wrong. I've not received any response - not even a note of concern - to this tale of torment. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069064
MDR Report Key6489405
Date Received2017-04-11
Date of Report2017-04-11
Date Added to Maude2017-04-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
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 Details

Brand NameSONABLATE 500
Generic NameSONABLATE 500
Product CodePLP
Date Received2017-04-11
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSONACARE MEDICAL


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2017-04-11

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