ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER manufactured by Cook Inc.

Event Text Entries

[92741226] Additional information: common device name is "gbo. " due to a technical issue, this information could not be saved in the proper field, so it is being recorded here. D4- rpn- ult12. 0-38-25-p-5s-cldm-tong-050399. This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, 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


[92741227] It was reported that prior to patient contact, leakage occurred from the catheter's hub area, a new product was used. There was no of injuries.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2017-03845
MDR Report Key7008991
Date Received2017-11-08
Date of Report2017-11-07
Date of Event2014-10-20
Date Mfgr Received2017-11-07
Device Manufacturer Date2013-09-01
Date Added to Maude2017-11-08
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 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 Report0

Device Details

Brand NameULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Product CodeEYI
Date Received2017-11-08
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
10 2017-11-08

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