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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC GIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number BNF-40-PB
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
Patient allegedly received a birds nest filter implanted on (b)(6) 2004. It is alleged that the plaintiff was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
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Brand NameGIANTURCO-ROEHM BIRD'S NEST FEMORAL VENA CAVA FILTER
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7151991
MDR Text Key95957539
Report Number1820334-2017-04672
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P850049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberBNF-40-PB
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 Received02/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/26/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2017 Patient Sequence Number: 1
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