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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
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 07/01/2015
Event Type  Injury  
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 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
Type of Device
LJE 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 Key7480815
MDR Text Key107188498
Report Number1820334-2018-01370
Device Sequence Number1
Product Code LJE
UDI-Device Identifier00827002481732
UDI-Public(01)00827002481732(17)180413(10)5798555
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Catalogue NumberULT8.5-8.5-22-NUCL-B-RH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/02/2018
Initial Date FDA Received05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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