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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Filtration Problem (2941)
Patient Problem Pulmonary Embolism (1498)
Event Date 11/09/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Catalog#: unknown but referred to as a cook celect platinum filter. Name and address for importer site: (b)(4). Event is currently under investigation.

 
Event Description

Description of event according to initial reporter: the patient had pulmonary embolisms while the filter was in place. The doctor is reporting this as adverse event; the filter did not do what it was intended to do.

 
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Brand NameUNKNOWN
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7081946
MDR Text Key93683518
Report Number3002808486-2017-02332
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/10/2017
Event Location No Information
Date Manufacturer Received02/14/2018
Was Device Evaluated By Manufacturer? No Answer Provided
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: 12/05/2017 Patient Sequence Number: 1
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