FDA.reportPublic FDA data

MAUDE MDR 1542584

MDR report key
1542584
Report number
3005249627-2009-00003
Event key
0
Event type
3
Date of event
2009-10-05
Date received
2009-11-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US
Phone
218-218-2183
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THE SPANNER TEMPORARY PROSTATIC STENTTEMPORARY PROSTATIC STENTABBEYMOOR MEDICAL INC.NZCSPNR-6HA216R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-11-1801. R

Event Narratives#

D

Patient 1

WHILE SOLICITING PRODUCT PERFORMANCE FEEDBACK FROM A PT, THE DEVICE MFR LEARNED THE PT HAD GONE TO THE EMERGENCY ROOM (ER) FOR BURNING ON URINATION FOUR DAYS AFTER SPANNER INSERTION. THE PT WAS GIVEN ANTIBIOTICS FOR A URINARY TRACK INFECTION; THE SPANNER STENT WAS NOT REMOVED. THE PT STATED HE WAS FEELING BETTER BY THE NEXT MORNING. HE CONTACTED THE NURSE AT THE PHYSICIAN'S OFFICE TO NOTIFY THEM, THEY STATED THAT THIS WAS FINE AND THAT HE DIDN'T NEED TO COME IN FOR ANY SPECIAL FOLLOW-UP. THE SPANNER STENT WAS INSERTED ON (B)(6) 2009. INDICATION FOR USE WAS URINARY RETENTION. DEVICE REMOVAL DATE IS UNK BUT THE PHYSICIAN STATED THE STENT WAS REMOVED AS SCHEDULE WITH NO UNTOWARD ADVERSE EFFECTS.

N

Patient 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. METHOD - NOT APPLICABLE (ACTUAL DEVICE WERE NOT EVALUATED). CONCLUSIONS - DEVICE NOT RETURNED - NO EVAL WILL BE PERFORMED.