FDA.reportPublic FDA data

MAUDE MDR 7346980

MDR report key
7346980
Report number
3009443653-2018-00009
Event key
0
Event type
3
Date received
2018-03-16
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. TES PROUD
Address
1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US
Phone
585-585-5853
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DEFLUX INJECTABLE GELAGENT,BULKING,INJECTABLE FOR GASTRO-UROLOGY USEBAUSCH + LOMBLNMDEFLUX INJECTABLE GELR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-1601. D; 2. R

Event Narratives#

N

Patient 1

INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

A PUBLISHED ARTICLE TITLED "DETERIORATION OF AUTOIMMUNE CONDITION ASSOCIATED WITH REPEATED INJECTION OF DEXTRANOMER/HYALURONIC ACID COPOLYMER: A CASE REPORT" REPORTS A DIAGNOSED CASE OF URETERAL STENOSIS APPROXIMATELY 2 YEARS AFTER INJECTION. A (B)(6)-YEAR OLD FEMALE PATIENT UNDERWENT ENDOSCOPIC DEFLUX INJECTION (EDI) FOR THE TREATMENT OF BILATERAL VUR OF GRADE 2. ANOTHER EDI WAS PERFORMED BECAUSE CYSTOURETHROGRAM AT 3 MONTHS POST-OPERATIVE SHOWED A PERSISTENT LEFT VUR OF GRADE 2. ONE AND A HALF YEARS AFTER, SHE CLAIMED LEFT FLANK PAIN. ULTRASOUND EXAMINATION SHOWED LEFT HYDRONEPHROSIS HYDROURETER, AND DELAYED EXCRETION FROM THE LEFT KIDNEY WAS OBSERVED BY MAG3. DELAYED ONSET OF URETERAL STENOSIS WAS DIAGNOSED, AND A URETERAL STENT WAS PLACED. SHE ALSO PRESENTED WITH ERYTHEMA ON BOTH CHEEKS AND RAYNAUD?S PHENOMENON; AUTOIMMUNE DISEASE WAS SUSPECTED. SINCE A RELATIONSHIP WITH THE AUTOIMMUNE DISEASE WAS ALSO SUSPECTED, A RISK OF DEVELOPING A HETEROCHRONIC RIGHT URETERAL STENOSIS WAS CONCERNED, AND URETEROCYSTONEOSTOMY (UCN) ON BOTH SIDES WAS PERFORMED, WITH SATISFACTORY POSTOPERATIVE COURSE. SIGNIFICANT INFILTRATION OF EOSINOPHIL TO THE AREA OF URETERAL STENOSIS WAS OBSERVED HISTOPATHOLOGICALLY, AND THE PATIENT DIED OF PULMONARY HEMORRHAGE DUE TO THROMBOTIC THROMBOCYTOPENIC PURPURA 4 MONTHS AFTER UCN. REACTIVE STENOSIS ACCOMPANIED BY ALLERGY WAS SUGGESTED IN THIS CASE. IT WAS CONSIDERED THAT THE TREATMENT OF EDI SHOULD BE DISCUSSED MORE CAREFULLY TO A PATIENT WHO PREDISPOSES TO ALLERGIES.

N

Patient 1

THE DEVICE WAS NOT RETURNED. A DEVICE LOT NUMBER WAS NOT REPORTED, SO A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.