THE SPANNER TEMPORARY PROSTATIC STENT SPNR-8HA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-17 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR-8HA manufactured by Abbeymoor Medical Inc..

Event Text Entries

[1899879] The physician reported one of his spanner patients had developed sepsis. The spanner was initially placed on (b)(6) 2010, for retention. Spanner stent was removed on (b)(6) 2010. The pt was hospitalized for one day; the day after spanner removal ((b)(6) 2010). The pt is currently doing fine and is wearing another spanner stent.
Patient Sequence No: 1, Text Type: D, B5


[8972453] The device was not returned for analysis. A review of the dhr was not performed. Every device lot is verified as sterile before release into inventory urinary tract infections are not a significant rate of occurrence.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005249627-2010-00008
MDR Report Key1971872
Report Source05
Date Received2011-01-17
Date of Report2011-01-14
Date of Event2010-08-09
Date Mfgr Received2010-12-21
Date Added to Maude2012-05-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street501 EAST SOO STREET
Manufacturer CityPARKERS PRAIRIE MN 56361
Manufacturer CountryUS
Manufacturer Postal56361
Manufacturer Phone2183386700
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHE SPANNER TEMPORARY PROSTATIC STENT
Generic NameTEMPORARY PROSTATIC STENT
Product CodeNZC
Date Received2011-01-17
Model NumberSPNR-8HA
Lot Number00256
Device Expiration Date2013-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBEYMOOR MEDICAL INC.
Manufacturer Address501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US 56361


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2011-01-17

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