PROLIEVE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-12 for PROLIEVE manufactured by .

Event Text Entries

[5093567] My husband, (b)(6), received in-office treatment for enlarged prostate using the prolieve system (microwave treatment). His urologist was (b)(6). He died 10 days after the procedure, in spite of 2 trips to (b)(6) hospital emergency department ((b)(6)) and numerous visits for follow-up with dr. (b)(6). He was in constant pain and unable to urinate normally after the procedure and until his death. No exploratory measures were taken to determine the cause of his pain and difficulties prior to this death; the only treatment he received was numerous insertion and removal of catheters, even though he continuously complained of great pain. We did inform the hospital of his history of a pulmonary embolism precipitated by dvt after an airline flight about 8 years prior; unsure of any connection/significance. He died at home the morning of (b)(6) just after awakening and calling out for help. He was not breathing and the emts were unable to revive him. He was taken to (b)(6) hospital (arrived unresponsive). An autopsy was not performed as i was told it would cost (b)(6) and is not covered by insurance. His death certificate lists immediate cause of death as cardiopulmonary respiratory arrest, underlying cause cardiovascular disease, although i am 100% certain his death was directly attributable to the prolieve procedure/treatment he received on (b)(6). Prior to that procedure he displayed no associated symptoms of pain or illness other than the common urological issues associated with bph.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038606
MDR Report Key4181882
Date Received2014-10-12
Date of Report2014-10-12
Date of Event2014-08-05
Date Added to Maude2014-10-20
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePROLIEVE
Generic NameMICROWAVE
Product CodeMEQ
Date Received2014-10-12
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2014-10-12

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