FDA.reportPublic FDA data

MAUDE MDR 7421222

MDR report key
7421222
Report number
1820334-2018-01090
Event key
0
Event type
3
Date of event
2015-04-10
Date received
2018-04-11
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
MR. LARRY POOL
Address
750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone
812-812-8128
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BANDER URETERAL DIVERSION STENT SETGBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERYCOOK INCGBL025226-OER Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-110

Event Narratives#

N

Patient 1

THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. BLANK FIELDS ON THIS FORM THAT HAVE NOT BEEN PREVIOUSLY SUBMITTED INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE.

D

Patient 1

THE COMPLAINANT REPORTED THAT THE WIRE STRIPPED AND BROKE PRIOR TO PATIENT CONTACT. THE DEVICE WAS UNRAVELING WHEN IT WAS REMOVED FROM THE PACKAGE OF THE BANDER URETERAL DIVERSION STENT SET AND A NEW WIRE WAS OPENED TO COMPLETE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT OR END USER AS A RESULT OF THE PRODUCT PROBLEM.