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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 Problems Migration or Expulsion of Device (1395); Structural Problem (2506); Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problems Embolus (1830); Pain (1994); Perforation of Vessels (2135)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device is unknown, but referred to as a celect filter. Occupation is non-healthcare professional. Investigation is still in progress.

 
Event Description

[pt] received a cook celect filter on (b)(6) 2011. [pt] underwent a surgical procedure in which a cook celect ivc filter was implanted. [pt] sustained personal injuries and damages after being implanted with the including cook celect ivc filter. [pt] sustained pain and suffering and loss of enjoyment of life and will continue to suffer such losses into the future.

 
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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 (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 
56868686
MDR Report Key10222929
MDR Text Key199713677
Report Number3002808486-2020-00674
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,Followup
Report Date 10/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2020
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 Received09/17/2020
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: 07/02/2020 Patient Sequence Number: 1
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