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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-FEM-TULIP
Device Problems Fracture (1260); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Weakness (2145); 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 gunther tulip filter. Occupation: non-healthcare professional. (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

It is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2011". 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 NameGUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
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 4632 DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov 4632 DK-46-32
DA   DK-4632
56868686
MDR Report Key8502762
MDR Text Key141565246
Report Number3002808486-2019-00394
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK090140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/27/2014
Device Catalogue NumberIGTCFS-65-1-FEM-TULIP
Device LOT NumberE2808000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/26/2019
Event Location No Information
Date Manufacturer Received05/16/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/27/2011
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: 04/11/2019 Patient Sequence Number: 1
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