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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. BARD DENALI IVC FILTER, INTRAVASCULAR, CARDIOVASCULAR

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BARD PERIPHERAL VASCULAR INC. BARD DENALI IVC FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Device Problem Bent (1059)
Patient Problems Thrombus (2101); Malaise (2359)
Event Date 01/01/2013
Event Type  Injury  
Event Description

I am (b)(6) and i am (b)(6) ssa representative. (b)(6) disability case was denied in error on (b)(6) 2018 and he is suffering from severe medical complications as a result of the ivc filter, being bent while being inserted in his chest wall. This claimant is at risk of loosing his leg, as his mother lost her leg and (b)(6) is in need of medical attention and those shots in his stomach, and he is in need of the medication, warfarin, which he was prescribed. This case was expediated and not decided on social security law by whomever decided. (b)(6) is in need of his ivc filter removed asap, these blood clots are moving down; jeopardizing his leg to be amputated. All of his medical records were not used which gave a synopsis of being approved by ssa law. (b)(6) is severely ill, because this filter has not be retrieved as it should have been. (b)(6) is currently not on medication, nor is he under a doctor's care. All his medical reports point to being disabled. (b)(6) is homeless, a poor historian, and has no money for medicine, or a physician's care facility.

 
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Brand NameBARD DENALI IVC
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC.
MDR Report Key7344766
MDR Text Key102766082
Report NumberMW5075912
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/01/2005
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/15/2018 Patient Sequence Number: 1
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