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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
Model Number N/A
Device Problem Crack (1135)
Patient Problems Abdominal Pain (1685); Chest Pain (1776)
Event Type  Injury  
Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be submitted upon completion.

 
Event Description

As reported by the fda via voluntary medwatch report mw5070240: "my name is (b)(6) sr. , and i am writing you in regards to a potential ivc filter claim. I have been keeping up with all the as on tv. I have contacted several of the 1-800 numbers. (b)(4) and (b)4) have both declined to take on my claim. You have listed only two brands of ivf filter. (b)(4) law firm was working with me until i told them the name of my ivc filter. Currently we are not accepting claims relating to this filter. The name of my ivc filter is birds nest vena cava filter. I found out recently that my bird's nest vena cava filter is cracked. I have been having problems with heart and pain in my stomach. There was an x-ray that was done on my stomach and that's how we found out that the ivc filter is cracked. There are other tests that have been done and now i'm waiting on the surgery. "what can you do to put this bird's nest vena cava filter on your list. " i also would like to know "do you have an attorney that will work with me on this ivc filter claim. " limited information has been received alleging the patient has suffered injuries. Therefore, this event will be reported under 21 cfr part 803.

 
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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 Key6721174
MDR Text Key80285167
Report Number1820334-2017-01664
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/18/2017 Patient Sequence Number: 1
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