ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER N/A UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-30 for ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER N/A UNKNOWN manufactured by Cook Inc.

Event Text Entries

[177369933] (b)(6). Occupation: manager. Pma/510(k) #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[177370134] It was reported an unknown patient required an ultrathane mac-loc locking loop multipurpose drainage catheter for a drainage procedure. When inserting the "drains" and once he gets past the hydrophilic coating, the operator noted "getting a lot of resistance with the skin. " it is currently unknown how many devices experienced this failure mode. As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00250
MDR Report Key9649225
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-30
Date of Report2020-02-12
Date Mfgr Received2020-02-06
Date Added to Maude2020-01-30
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 ContactUNK JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Generic NameGBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
Product CodeGBO
Date Received2020-01-30
Model NumberN/A
Catalog NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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
10 2020-01-30

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