RUTNER SUPRAPUBIC BALLOON CATHETER SET G15261 081912

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-05-03 for RUTNER SUPRAPUBIC BALLOON CATHETER SET G15261 081912 manufactured by Cook Inc.

Event Text Entries

[107259349] (b)(4). Additional procedure was required. 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.
Patient Sequence No: 1, Text Type: N, H10


[107259350] It was reported that two days after placement, the rutner suprapubic balloon catheter fell out of the patient, and its balloon seemed deflated. Another device was placed, but there were no further injuries aside from the replacement procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-01376
MDR Report Key7483457
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2018-05-03
Date of Report2018-05-03
Date of Event2015-10-07
Date Mfgr Received2018-05-02
Device Manufacturer Date2014-10-30
Date Added to Maude2018-05-03
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 FDA3
Event Location3
Manufacturer ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8128294891
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRUTNER SUPRAPUBIC BALLOON CATHETER SET
Generic NameKOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)
Product CodeKOB
Date Received2018-05-03
Model NumberG15261
Catalog Number081912
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-05-03

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