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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 Insufficient Information
Event Type  Injury  
Manufacturer Narrative

Event reported by the manufacturer under mdr #3002808486-2020-00096.

 
Event Description

It is alleged that "[pt] received a cook celect filter on (b)(6) 2008. It is alleged that the [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided. ".

 
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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 Key9646760
Report Number3005580113-2020-00115
Device Sequence Number1
Product CodeDTK
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2020
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?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2020
Distributor Facility Aware Date01/15/2020
Event Location Other
Date Report TO Manufacturer01/15/2020
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: 01/30/2020 Patient Sequence Number: 1
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