RADIADYNE ENDORECTAL BALLOON

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for RADIADYNE ENDORECTAL BALLOON manufactured by Radiadyne, Llc.

Event Text Entries

[110746922] Had prostate removed because of very dangerous cancer - (b)(6) 2016. Doctor encouraged radiation to kill any residual cancer. Began 39 days of radiation on (b)(6) 2017. A total of 25 days at 180 centagrays (approx 200 seconds duration) and 14 days at 180 centagrays (approx 90 seconds duration). During those 39 treatments they inserted a balloon device up where the sun doesn't shine. The radiadyne endorectal balloon was supposed to keep the prostate from moving during the radiation treatment. When i pointed out that i didn't have a prostate, the tech rep didn't have an answer. They would also tell me that it prevented radiation damage. I also knew that was not the answer because the beam started firing from under the table and then took a number of circles. A colonoscopy on (b)(6) 2018 showed radiation damage to my rectal area. My inquiries to the radiadyne company in (b)(4) confirmed that their only purpose was to immobilize the prostate during radiation treatment. Open and view at radiadyne. Com/immobilocpatients. Php and also radiadyne. Com/immobilocvideo. Php. My concern in the use of the balloon devices is that it was used needlessly and with faulty reasoning in my case. Remember: i had no prostate! It adds to the cost of treatment and it's also uncomfortable plus being a great insult to my sense of manly dignity. Those massive doses of radiation seem to have done the job and the last psa test was 0. 23. The machine that was used was the varian medical systems true beam machine and their program was prostate 4500 for 25 days and the prostate 2520 plan for 14 days. The 4500 and 2520 are the respective total doses of centagray radiation received. I would ask that you inquire and see if these balloons are being used needlessly and then prohibit the use unless it is medically needed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077689
MDR Report Key7582136
Date Received2018-06-07
Date of Report2018-06-05
Date of Event2017-02-06
Date Added to Maude2018-06-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag0
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 NameRADIADYNE ENDORECTAL BALLOON
Generic NamePROSTATE IMMOBILIZER RECTAL BALLOON
Product CodePCT
Date Received2018-06-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerRADIADYNE, LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-07

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