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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL GUNTHER TULIP INFERIOR VENA CAVA FILTER

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COOK MEDICAL GUNTHER TULIP INFERIOR VENA CAVA FILTER Back to Search Results
Model Number FEMORAL DEPLOYMENT
Event Date 05/26/2015
Event Type  Injury  
Event Description

In 2009, i was hospitalized with severe pneumonia, possible h1n1. Hp decided to implant gunther tulip femoral ivc filter. Cook medical (b)(6) 2014, unrelated hp urgent care visit. The gunther tulip ivc filter is discovered: fractured separated leg lodged in lower lumbar of spine broken off; separate broken leg in caval wall; the entire remaining gunther tulip filter is caudally migrating towards my spine. Other than the horrible flu, i am an under 50 healthy female. The ongoing year to present has been filled of dr. Refusals of services and denial of authorizations. Saw doctor after doctor to conclude with 5 massive surgeries to remove embedded cook filter. Have an 11 inch scar, 1/4" width in abdominal exploration and retrieval operation. Near one year anniversary coming up. I will never be the same inside or out. Emotionally and physically in pain and weak. Still doctors appointment after appointment.

 
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Brand NameGUNTHER TULIP INFERIOR VENA CAVA FILTER
Type of DeviceGUNTHER TULIP INFERIOR VENA CAVA FILTER
Manufacturer (Section D)
COOK MEDICAL
MDR Report Key5513394
Report NumberMW5060951
Device Sequence Number1
Product CodeDTK
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 03/16/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2016
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberFEMORAL DEPLOYMENT
Device Catalogue Number8.5-1-FEM-TULIP
Device LOT NumberGUNTHER TULIP 1GTCFS-65-1 ?
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/16/2016 Patient Sequence Number: 1
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