CESIUM RADIOACTIVE SEEDS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-26 for CESIUM RADIOACTIVE SEEDS manufactured by .

Event Text Entries

[103781412] Cesium seeds broke apart into powder and some stayed as seeds and some in groin area and base of penis and some into anus. The cesium dust was inhaled unknowingly. Cesium seeds logged inside of bowel and in scrotum in area where they were placed between anus low bowel. Low back and base of penis. Caused a bad radiation sun burn to face and throat. Also seeds implanted into ragged rocks in feces. Cause pain and anal bleeding and soreness in lower bowel. Hard to evacuate bowel, hard to sit, travel and sleep is interrupted every hour to try and feces. I am past 30 days + of implant, and problems continue. Lack of sleep. Causes dizziness, extreme tiredness, lack of concentration, irritable and extreme pain, hard not to cry out. Broke teeth, trying to deal with pain. Weight loss of 10-15 lbs. Feel helpless inside of me and can't remedy problem. Forgive typing hard to sit due to pain and lack of concentration. Note none and done for pt. Emotionally feel violated and helpless. Use frequent prep h vaseline and sun burn medicine. Not warned of these side effects. Thanks for your consideration to provide input as none of these effects of cesium given to me. A lot of pain to sit and type in this message and lack of concentration as want to cry out in pain. Horrible experience. Feels like torture as no way to remedy problem except time. Feel like the seeds are trapped inside of me and can do nothing about it. Great loss of quality of life.
Patient Sequence No: 0, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5076164
MDR Report Key7373281
Date Received2018-03-26
Date of Report2018-03-24
Date Added to Maude2018-03-27
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 Details

Brand NameCESIUM RADIOACTIVE SEEDS
Generic NameCESIUM RADIOACTIVE SEEDS
Product CodeKXK
Date Received2018-03-26
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
001. Other; 2. Deathisabilit 2018-03-26

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