SILICONE MALECOT CATHETER 083814

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-29 for SILICONE MALECOT CATHETER 083814 manufactured by Cook Inc.

Event Text Entries

[93189719] (b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[93189720] The user facility reported during a hutch diverticulectomy and right ureteral reimplant procedure, the distal portion of the catheter and cage broke off. The patient was returned to the operating room to remove the retained portion of the catheter located in the retroperitoneum. No adverse effects or consequences were reported to the patient due to this occurrence. Additional information has been requested from the customer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2017-04330
MDR Report Key7066773
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-11-29
Date of Report2018-03-01
Date of Event2017-10-30
Date Mfgr Received2018-02-02
Date Added to Maude2017-11-29
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 Phone8123392235
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSILICONE MALECOT CATHETER
Generic NameKOB CATHETER, SUPRAPUBIC (AND ACCESSORIES)
Product CodeKOB
Date Received2017-11-29
Catalog Number083814
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-11-29

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