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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
Catalog Number UFH-630-R
Device Problem Break (1069)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
As reported, the string (tether) on the universa firm ureteral stent broke.There were no adverse effects to the patient reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: customer occupation = (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Manufacturer Narrative
Additional information: b5; h6: health effect - clinical code (annex e) and health effect - impact code (annex f).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
It was reported in additional information that the nurse (rn) opened the the device packaging to the sterile field, and the staff noticed that the string was not attached to the stent.The device was then removed from the field and sequestered.The device did not make patient contact, and a new stent was was obtained to complete the procedure.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d9, h3 this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
 
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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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key18192907
MDR Text Key328944753
Report Number1820334-2023-01610
Device Sequence Number1
Product Code FAD
UDI-Device Identifier10827002499086
UDI-Public(01)10827002499086(17)260823(10)15624182
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/02/2024
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 Catalogue NumberUFH-630-R
Device Lot Number15624182
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/08/2023
Initial Date FDA Received11/22/2023
Supplement Dates Manufacturer Received11/24/2023
01/08/2024
Supplement Dates FDA Received12/15/2023
02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2023
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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