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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 Fracture (1260); Migration (4003)
Patient Problems Diarrhea (1811); Cramp(s) (2193); Device Embedded In Tissue or Plaque (3165)
Event Date 09/09/2019
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. Investigation is still in progress.

 
Event Description

"primary leg detached from the filter. Unknown status of the leg in the patient. Filter was placed in 2012. Filter was a celect. Treatment is still to be determined. " additional information received 26sep2019. "this patient presented to the er for cramping and diarrhea and had a ct based on this presentation and they found the ivc filter with a broken leg. Physician has scheduled the removal of the filter itself for (b)(6) 2019. The filter is situated in the right psoas- which is a long fusiform muscle located on the side of lumbar region of the column and brim of the lesser pelvis. " the plan is to retrieve filter (b)(6) 2019.

 
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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 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key9149614
MDR Text Key161936783
Report Number3002808486-2019-01608
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 COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2019
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? Device Returned To Manufacturer
Date Returned to Manufacturer11/08/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2020
Was Device Evaluated By Manufacturer? Yes
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: 10/03/2019 Patient Sequence Number: 1
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