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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK MEDICAL UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Pain (1994); Palpitations (2467); No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Occupation: non-healthcare professional. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Event Description

It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter device on (b)(6) 2007. It is alleged that the patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
COOK MEDICAL
sandet 6, dk-4632
bjaeverskov DK-46 32
DA DK-4632
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8343564
MDR Text Key136267423
Report Number1820334-2019-00468
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
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 Received06/19/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/15/2019 Patient Sequence Number: 1
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