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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 Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Cramp(s) (2193); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Blank fields on this form indicate the information is unknown or unavailable. Catalog# is unknown but referred to as cook celect filter. (b)(4). Investigation is still in progress.
 
Event Description
It is alleged that "patient received a celect platinum filter on (b)(6) 2012". Patient alleges "filter migrated from its original location". It is alleged that patient was injured without further explanation. Hospital and medical records have been requested but not yet provided.
 
Manufacturer Narrative
Exemption number e2016032. (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
This additional information received on 2may2018 as follows: ¿[pt] allegedly received an implant on (b)(6) 2012 via the left jugular vein due to deep vein thrombosis, breast cancer, history of pulmonary embolism. [pt] is alleging migration. [pt] further alleging pain in lower right side, cramping, mental and emotional anguish without further details, pain in right side and back.
 
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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 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key7410582
MDR Text Key104802671
Report Number3002808486-2018-00429
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 Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/27/2018
Event Location No Information
Date Manufacturer Received06/08/2018
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: 04/10/2018 Patient Sequence Number: 1
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