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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL GUNTHER TULUP IVC FILTER

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COOK MEDICAL GUNTHER TULUP IVC FILTER Back to Search Results
Event Type  Injury  
Event Description

In (b)(6) 2009, i was admitted to (b)(6) hospital - (b)(6) with severe pneumonia. So severe i fell into a coma somehow within hours of admittance. Remained comatose for approx four weeks (after 2 weeks (b)(6) decided i, at (b)(6), healthy, weight appropriate, non-smoker was deemed needing a gunther tulip ivc filter. Cook medical authorization was supposedly obtained by my out of state mother. Bringing us to present day (b)(6) 2014, in a non-related admit to the very same hospital, (b)(6) lower bowel scan was performed for a blockage. I was informed by (b)(6) hospital. My ivc filter had fractured and migrated caudally towards my spine. What ivc filter and what are you (b)(6) speaking of denying. (b)(6) stated well who put this in you. I stated well this very hospital did. No discharge papers were given in 2009 on this procedure, no item number, no handy card that i learned i was supposed to have identifying this implant with mri and cat scan warning. No info at all. Especially that this was a temporary device, meant to be removed after need had surpassed. I don't believe it was ever needed in the first place. The hospital used me as a guinea pig with a device provided by cook medical and (b)(6) subsidies. Numerous contact with hospital to get medical records denied. Over and over i am told there is no record, this is a shelf item. I am denied healthcare all over. So in (b)(6) no doctor will see me due to this item and its affects. Months of attempts and still stonewall by (b)(6) hospital. To this date, i do not know the exact manufactures guidelines or warnings.

 
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Brand NameGUNTHER TULUP IVC FILTER
Type of DeviceIVC FILTER
Manufacturer (Section D)
COOK MEDICAL
MDR Report Key4724200
Report NumberMW5042199
Device Sequence Number1
Product CodeDTK
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
OTHER Device ID Number00797299

Patient TREATMENT DATA
Date Received: 04/16/2015 Patient Sequence Number: 1
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