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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  
Event Description

Description of event according to initial reporter: "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. " "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. " patient outcome: 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
MDR Report Key9147301
MDR Text Key161402276
Report Number3005580113-2019-00478
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 Distributor
Reporter Occupation
Type of Report Initial
Report Date 10/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
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?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/02/2019
Distributor Facility Aware Date09/11/2019
Event Location Hospital
Date Report TO Manufacturer09/11/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 10/02/2019 Patient Sequence Number: 1
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