MAUDE MDR 7373281

MDR report key
7373281
Report number
MW5076164
Event key
0
Event type
3
Date received
2018-03-26
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CESIUM RADIOACTIVE SEEDSCESIUM RADIOACTIVE SEEDSKXKI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
02018-03-2601. O; 2. S

Event Narratives#

D

Patient 0

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.