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U.S. Department of Health and Human Services

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

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Atrial Fibrillation (1729); Thrombus (2101); Perforation of Vessels (2135); No Information (3190)
Event Type  Injury  
Manufacturer Narrative

Non-healthcare professional. Catalog number and lot number are unknown; however, there is no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e. G. Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava. It has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date. Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c. F. R. 803. 56.

 
Event Description

It is alleged that the patient received a gunther tulip on (b)(6) 2010. 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 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 Key9021530
MDR Text Key162350240
Report Number1820334-2019-02287
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
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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 Received10/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/13/2019 Patient Sequence Number: 1
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