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MAUDE MDR 4603092

MDR report key
4603092
Report number
MW5041370
Event key
0
Event type
3
Date of event
1998-08-01
Date received
2015-03-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PVAUTERINE ARTERY EMBOLIZATIONNAJ

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-0501. H

Event Narratives#

D

Patient 1

SHE WAS A PHYSICIANS ASSISTANT. HAD UAE FOR 6 MONTH SIZE FIBROID. TWO MONTHS POST UAE STARTED PASSING NECROTIC DEBRIS AND ANAEROBIC VAGINAL DISCHARGE. SHE WAS ADMITTED TO (B)(6) HOSP AND A DRAIN WAS PLACED THRU THE CERVICAL OS FOR ELEVEN DAYS. WHEN DRAIN WAS REMOVED SHE BECAME SEPTIC. ON (B)(6) 98, TWO WEEKS AFTER DRAIN WAS REMOVED, SHE UNDERWENT TOTAL ABDOMINAL HYSTERECTOMY. SHE HAD PERSISTENT PERINEUM BURNING, BLADDER WAS FOUND TO HAVE SCAR TISSUE RESULTING FROM POSSIBLE PERFORATION DURING HYSTERECTOMY. MULTIPLE NECROTIC TISSUE WITH BACTERIAL GROWTH WAS FOUND. SHE WAS DISCHARGED WITH UTI, ENTEROCOCCUS. SHE CONTINUES TO HAVE PERSISTENT PERINEUM BURNING AND IC SEEN ON CYSTOSCOPY UNDER GENERAL ANESTHESIA. SHE CONTINUES NEUROPATHIC, BUT THAT SHE HAS A SMALL FISTULA VESICOVAGINAL CUFF. NO DOCTOR HAS SEEN IT. SHE HAS BEEN UNABLE TO HAVE INTERCOURSE DUE TO THE BURNING. AN INTERSTIM WAS PLACED S4 WITH SOME DECREASE IN PAIN. CONTINUES TO HAVE BURNING 24/7 AND ALWAYS IN THE SAME AREA.