THE SPANNER TEMPORARY PROSTATIC STENT SPNR- SPNR-6C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-03-17 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- SPNR-6C manufactured by Abbeymoor Medical Inc..

Event Text Entries

[1070168] The patient received a spanner in 2007 for post transurethral microwave thermotherapy (tumt) retention. The patient returned for a follow up visit, per the physician's request about two days later. At that time, the physician performed a transrectal ultrasound (trus) which appeared to show the device may have migrated into the bladder but x-ray showed the spanner had partially migrated. The anchor appeared to be just above the sphincter. The physician repositioned the device anchor and sent the patient home. The patient returned at about one week later, after nine days of spanner wear with low urinary flow, cystoscopy showed a complete migration of the device into the patient's bladder. The physician removed the spanner. No information was provided on how the device was removed or any further follow up with the patient after device removal.
Patient Sequence No: 1, Text Type: D, B5


[8188032] The device was not returned for evaluation. A review of device history records (dhr) for the relevant spanner lot revealed no indication that the device used did not meet specifications. (actual devices were not evaluated).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005249627-2009-00001
MDR Report Key1346052
Report Source05,07
Date Received2009-03-17
Date of Report2009-03-13
Date of Event2007-07-27
Date Mfgr Received2007-07-30
Device Manufacturer Date2007-06-01
Date Added to Maude2009-03-24
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 Received2009-03-17
Model NumberSPNR-
Catalog NumberSPNR-6C
Lot Number1
Device Expiration Date2009-06-30
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. Required No Informationntervention 2009-03-17

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