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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY
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COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY Back to Search Results
Catalog Number ULT8.5-8.5-22-NUCL-B-RH
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/01/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).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 patient returned after two weeks as the hub on the external portion of the ultrathane cope nephroureterostomy catheter had fallen off.The catheter was replaced with another product with no harm to the patient.
 
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Brand Name
ULTRATHANE COPE NEPHROURETEROSTOMY SET
Common Device Name
LJE CATHETER, NEPHROSTOMY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7480815
Report Number1820334-2018-01370
Device Sequence Number16226521
Product Code LJE
UDI-Device Identifier00827002481732
UDI-Public(01)00827002481732(17)180413(10)5798555
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2015
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/02/2018
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? No
Operator of Device Health Professional
Device Catalogue NumberULT8.5-8.5-22-NUCL-B-RH
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/02/2018
Initial Report FDA Received Date05/02/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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