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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ULTRATHANE COOK-COPE TYPE LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
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COOK INC ULTRATHANE COOK-COPE TYPE LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY Back to Search Results
Catalog Number ULT16.0-38-40-P-32S-BCL-HC
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/16/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that before insertion the doctor noted that the catheter has a split end.
 
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Brand Name
ULTRATHANE COOK-COPE TYPE LOCKING LOOP BILIARY DRAINAGE CATHETER
Type of Device
GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7034717
MDR Text Key93078458
Report Number1820334-2017-04093
Device Sequence Number1
Product Code GCA
UDI-Device Identifier00827002092051
UDI-Public(01)00827002092051(17)180722(10)NS6053408
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberULT16.0-38-40-P-32S-BCL-HC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2015
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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