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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL
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COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL Back to Search Results
Model Number G49866
Device Problems Crack (1135); Torn Material (3024)
Patient Problem No Patient Involvement (2645)
Event Date 04/25/2016
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 the universa firm ureteral stent was already cracked/torn when the package was opened.The device did not make patient contact, and there was no impact to the patient or users.
 
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Brand Name
UNIVERSA FIRM 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 Key7426615
MDR Text Key105882434
Report Number1820334-2018-01079
Device Sequence Number1
Product Code FAD
UDI-Device Identifier00827002498662
UDI-Public(01)00827002498662(17)180820(10)6139842
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,use
Reporter Occupation Other
Type of Report Initial
Report Date 04/12/2018
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? Yes
Device Operator Health Professional
Device Model NumberG49866
Device Catalogue NumberUFH-526
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/09/2018
Initial Date FDA Received04/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/20/2015
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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