FDA.reportPublic FDA data

MAUDE MDR 1896936

MDR report key
1896936
Report number
2183558-2010-00046
Event key
0
Event type
3
Date received
2010-11-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. BRIAN SCHMIDT
Address
1601 WEST RIVER ROAD NORTH MINNEAPOLIS MN 55411 US
Phone
612-612-6123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CYSTOCARE GOLDURINE LEG BAGCOLOPLAST MANUFACTURING US, LLCNNWUB04201002UB042010021507517R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-11-1101. R

Event Narratives#

D

Patient 1

(B)(6). ACCORDING TO THE INFORMATION RECEIVED, DURING A OPERATION FOR THE RESECTION OF A BLADDER TUMOR, A LEG COLLAPSED (FIRST USING). THIS RESULTED IN A BLOCKED CATHETER SO THERE WAS URINARY RETENTION AND CLOT FORMATION. THE BAG WAS CHANGED AND NO PRODUCT WAS KEPT.

N

Patient 1

INFORMATION RECEIVED INDICATED THERE ARE NO SAMPLES TO RETURN FOR EVALUATION. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.