FDA.reportPublic FDA data

MAUDE MDR 9460434

MDR report key
9460434
Report number
1820334-2019-03097
Event key
0
Event type
3
Date of event
2019-11-29
Date received
2019-12-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. JENNIFER CANADA
Address
750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone
812-812-8123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTRATHANE COPE NEPHROURETEROSTOMY SETLJE CATHETER, NEPHROSTOMYCOOK INCLJEN/AULT8.5-8.5-28-NUCL-B-RHUNKNOWNY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-1201. R

Event Narratives#

N

Patient 1

INITIAL REPORTER OCCUPATION: SR. CLINICAL RISK ADVISOR. REPORT SOURCE-OTHER: COUNTRY OF ORIGIN: (B)(6), MDIP REPORT. PMA/510(K) #: PREAMENDMENT. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

D

Patient 1

IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET IN THE BLADDER, URETER, AND KIDNEY FOR DRAINAGE. A DAY AFTER PLACEMENT, IT WAS OBSERVED THE "TUBE CAME APART AT THE TUBE/HUB JUNCTION." ADDITIONALLY, THE DEVICE WAS LEAKING BECAUSE THE "TUBE WAS DISLODGED" FROM THE HUB. THE DEVICE WAS SUCCESSFULLY REPLACED WITH A NEW, SIMILAR DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.