ULTRATHANE MULTIPURPOSE DRAINAGE SET N/A CLDM-10.2-MH

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 2020-01-03 for ULTRATHANE MULTIPURPOSE DRAINAGE SET N/A CLDM-10.2-MH manufactured by Cook Inc.

Event Text Entries

[178151202] Initial reporter also sent report to fda: unknown. 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


[178151203] It was reported an unknown patient required placement of an ultrathane multipurpose drainage set during a percutaneous transhepatic cholangiodrainage exchange procedure. The operator reported the drainage device was inserted in the body over the wire guide. When attempting to remove the wire from the catheter, "the wire guide got caught in the pig tail. " the wire was removed from the catheter "somehow" and "the catheter was placed in the body". 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 Number1820334-2020-00049
MDR Report Key9546432
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-01-03
Date of Report2020-03-10
Date of Event2019-12-19
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-10-14
Date Added to Maude2020-01-03
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 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 MULTIPURPOSE DRAINAGE SET
Generic NameGBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
Product CodeGBO
Date Received2020-01-03
Returned To Mfg2020-01-09
Model NumberN/A
Catalog NumberCLDM-10.2-MH
Lot Number10039218
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 2020-01-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.