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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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COOK INC UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Edema (1820); Pain (1994); Perforation of Vessels (2135); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Unknown if the following patient and device codes are listed in the ifu. Product information not provided. (b)(4). Corrected data based on new information received: adverse event to product malfunction. Serious injury to malfunction. Blank fields on this form indicate the information is unknown or unavailable, or unchanged. The event is currently under investigation. A supplemental report will be provided upon conclusion. 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. Unknown if the following patient and device codes are listed in the ifu. Product information not provided. (b)(4). Corrected data based on new information received: adverse event to product malfunction. Serious injury to malfunction. Blank fields on this form indicate the information is unknown or unavailable, or unchanged. The event is currently under investigation. A supplemental report will be provided upon conclusion.
 
Event Description
This additional information received on 06/21/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2004 via the right femoral vein due to bilateral pe and dvt in right femoral and popliteal veins. Plaintiff is alleging edema, pain, swelling, stiffness, vena cava perforation, and inability to stand for long periods.
 
Manufacturer Narrative
The event is currently under investigation. A supplemental report will be submitted upon completion.
 
Event Description
It is alleged that [pt] received a cook gunther tulip on (b)(6) 2004. It is alleged that the patient 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)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6601496
MDR Text Key195042989
Report Number1820334-2017-01096
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
Report Date 07/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date05/10/2017
Event Location No Information
Date Manufacturer Received06/21/2017
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: 05/31/2017 Patient Sequence Number: 1
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