• 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 GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

  • 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 GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G21360
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Cramp(s) (2193); Numbness (2415)
Event Type  Malfunction  
Manufacturer Narrative

The previous mdr was submitted by william cook europe under manufacturer report reference number 3002808486-2019-00873. Additional information provided determined that this device was manufactured by cook inc. With the submission of this initial report, cook inc informs that all future submissions regarding this complaint will be handled under manufacturer report number referenced in this initial medwatch report. Occupation: non-healthcare professional. A follow-up medwatch report will be submitted if additional relevant information becomes available.

 
Event Description

Update 30 aug 2019: patient allegedly received an implant on (b)(6) 2014. Patient is alleging "i have pain in both legs, cramps, numbness. I have to elevate my legs all the time to feel better". This report is for the (b)(6) 2014 implant. A separate report will be submitted for the (b)(6) 2014 filter.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9126300
MDR Text Key160435877
Report Number1820334-2019-02436
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/01/2016
Device MODEL NumberG21360
Device Catalogue NumberIGTCFS-65-UNI
Device LOT Number4849458
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/21/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-