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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL
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COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL Back to Search Results
Model Number G15147
Device Problems Detachment Of Device Component (1104); Fracture (1260); Out-Of-Box Failure (2311)
Patient Problem No Patient Involvement (2645)
Event Date 09/20/2016
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 prior to the procedure, the pigtail ureteral stent was fractured and detached when opening the package.It was further noted the stent was returned in three pieces.
 
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Brand Name
FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
Type of Device
FAD STENT, URETERAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7413209
MDR Text Key105507895
Report Number1820334-2018-01058
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00827002151475
UDI-Public(01)00827002151475(17)190614(10)7043062
Combination Product (y/n)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other
Type of Report Initial
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG15147
Device Catalogue Number133628
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 Manufactured06/14/2016
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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