ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER N/A ULT10.2-38-25-P-6S-CLM-RH

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 2020-01-08 for ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER N/A ULT10.2-38-25-P-6S-CLM-RH manufactured by Cook Inc.

Event Text Entries

[177400212] Occupation: ir 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


[177400213] It was reported an ultrathane mac-loc locking loop multipurpose drainage catheter was placed in an unknown patient for drainage. Once the drain was placed, the physician noted "a crack in the hub of the drain. " the drain was removed and replaced with a new, similar device. Additional information indicated that the device leaked where the hub meets the catheter. 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 Number1820334-2020-00088
MDR Report Key9566073
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-08
Date of Report2020-03-05
Date of Event2019-10-28
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-08-29
Date Added to Maude2020-01-08
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 ContactMRS. 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 Received2020-01-08
Returned To Mfg2019-12-19
Model NumberN/A
Catalog NumberULT10.2-38-25-P-6S-CLM-RH
Lot Number9981291
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
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
10 2020-01-08

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