FDA.reportPublic FDA data

MAUDE MDR 7481251

MDR report key
7481251
Report number
1820334-2018-01372
Event key
0
Event type
3
Date received
2018-05-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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
1RUTNER SUPRAPUBIC BALLOON CATHETER SETKOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)COOK UROLOGICAL INCKOBG14920081916R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-0201. R

Event Narratives#

N

Patient 1

(B)(4). 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.

D

Patient 1

IT WAS REPORTED THAT THE RUTNER SUPRAPUBIC BALLOON CATHETER FELL OUT OF THE PATIENT ONE DAY AFTER BEING PLACED. THE BALLOON WAS REINFLATED TO PLACE THE DEVICE AGAIN, BUT IT STOPPED DRAINING TWO DAYS LATER. A NEW CATHETER WAS PLACED, BUT THERE WERE NO FURTHER INJURIES ASIDE FROM THIS REPLACEMENT PROCEDURE.