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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 Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Initial reporter occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged tulip is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.
 
Event Description
It is alleged that the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2014, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.
 
Manufacturer Narrative
Additional information provided determined that this device was manufactured by cook inc.With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.Blank fields on this form indicate the information is unknown or unavailable.
 
Event Description
Additional information provided determined that this device was manufactured by cook inc.With the submission of this follow up report, william cook europe informs that this complaint has been transferred from william cook europe to cook inc.
 
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Brand Name
UNKNOWN
Type of Device
DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6, dk-4632
bjaeverskov
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6, dk-4632
bjaeverskov
Manufacturer Contact
lissi walmann
sandet 6, dk-4632
bjaeverskov 
56868686
MDR Report Key12516420
MDR Text Key272901185
Report Number3002808486-2021-01812
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 Other,Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/25/2021
Initial Date FDA Received09/22/2021
Supplement Dates Manufacturer Received01/10/2022
Supplement Dates FDA Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient SexFemale
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