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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
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COOK INC ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number ULT8.5-38-15-P-5S-CLDM-HC
Health Effect - Clinical Code No Information (3190)
Date of Event 06/04/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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.
 
Event or Problem Description
It was reported that the device was placed and stitched to the patient with the bag, leakage of body fluid was noted from the white plastic area.The device was replaced.
 
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Brand Name
ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Common Device Name
GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7013877
Report Number1820334-2017-03951
Device Sequence Number940070
Product Code GBO
UDI-Device Identifier00827002113862
UDI-Public(01)00827002113862(17)180304(10)5691713
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberULT8.5-38-15-P-5S-CLDM-HC
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/07/2017
Initial Report FDA Received Date11/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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