Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL Back to Search Results
Model Number N/A
Device Problem Material Separation (1562)
Patient Problems Surgical procedure, additional (2564); No Code Available (3191)
Event Date 07/16/2015
Event Type  Injury  
Event Description
The sof-flex pediatric double pigtail ureteral stent set was placed in a child sometime in march.When the child got up to go to the restroom the stent fell out.When the physician went to remove the rest of the stent, it came out in pieces.Per the initial reporter, no other stent was placed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Manufacturer Narrative
Patient code: additional surgical procedure is not labeled.Material separation is not labeled.
 
Manufacturer Narrative
(b)(4).Event evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control and specifications were conducted for the purpose of this investigation.The product was not returned for evaluation.The device history record and documents relevant to the manufacture of the device were reviewed.There was no evidence to suggest that the product was manufactured incorrectly.Based on the evidence available, the cause for this complaint is unknown.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.
 
Event Description
The sof-flex pediatric double pigtail ureteral stent set was placed in a child sometime in march.When the child got up to go to the restroom the stent fell out.When the physician went to remove the rest of the stent, it came out in pieces.Per the initial reporter, no other stent was placed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SOF-FLEX PEDIATRIC 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
8123392235
MDR Report Key4976928
MDR Text Key6083053
Report Number1820334-2015-00473
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number039510
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/16/2015
Device Age3 YR
Event Location Hospital
Initial Date Manufacturer Received 07/16/2015
Initial Date FDA Received08/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-