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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC OPEN-END URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
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COOK INC OPEN-END URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 020116
Device Problems Partial Blockage (1065); Occlusion Within Device (1423)
Patient Problem No Patient Involvement (2645)
Event Date 12/15/2015
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 prior to the procedure, there was a blockage when the thread was passed through the open-end ureteral catheter.It was further noted that the distal catheter was occluded with a small amount of green plastic.There was no patient contact.
 
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Brand Name
OPEN-END URETERAL CATHETER
Type of Device
GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7409564
MDR Text Key105276570
Report Number1820334-2018-01052
Device Sequence Number1
Product Code GBL
UDI-Device Identifier00827002144309
UDI-Public(01)00827002144309(17)180816(10)6126141
Combination Product (y/n)N
Reporter Country CodeNZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other
Type of Report Initial
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number020116
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2015
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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