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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 Unintended Movement (3026); Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091); Perforation of Vessels (2135); Cramp(s) (2193); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Manufacturer reference # (b)(4). Exemption number e2016032. (b)(4). Corrected data based on new information received: adverse event to product problem. Type of reportable event: serious injury to malfunction. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 31/jan/2018 as follows: patient received an implant on (b)(6) 2010 via the right common femoral vein due to intracranial hemorrhage. Patient is alleging severe pain, cramps, weakness, anxiety, mental anguish and stress due to the device.
 
Manufacturer Narrative
(b)(4). Catalog# is unknown but referred to as cook celect filter. Name and address for importer site: (b)(4). Pma 510(k): since catalog# is unknown 510(k) could be either k061815, k073374 or k090140. (b)(4). It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date. Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c. F. R. 803. 56.
 
Event Description
Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2010". Patient outcome: it is alleged that [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
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632, IN 47404
8004574500
MDR Report Key7198731
MDR Text Key280476695
Report Number3002808486-2018-00134
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 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2018
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 Date01/03/2018
Event Location No Information
Date Manufacturer Received04/02/2018
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: 01/17/2018 Patient Sequence Number: 1
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