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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIC LINE

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PIC LINE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Syncope (1610); Stroke/CVA (1770); Congestive Heart Failure (1783); Dyspnea (1816); Head Injury (1879); Unspecified Infection (1930); Myocardial Infarction (1969); Pain (1994); Pneumonia (2011); Hot Flashes/Flushes (2153); Pressure Sores (2326)
Event Date 02/25/2016
Event Type  Injury  
Event Description
On (b)(6) hospitalized again for congestive heart failure. Had back pain and short of breath, went to uncc er, heart infarction. Had a heart cath put on meds, diet and set to what is wellness center. I had my first foot surgery by an orthopedic surgeon in 2010 ((b)(6)) and had a nerve block and iv sedation for joint or big toe be removed due to infection, pressure ulcer was shown. Tendon in right leg cut and stitched and i had to wear a head cast for 6 weeks. I was placed on pravastatin for 14 days in (b)(6). In (b)(6) 2010, i had a stroke and a mini on (b)(6), they did a heart cath which caused me to have another stroke that affected my right side of my body. In (b)(6) 2014, i had a hot flash and passed out, cut my head, had 5 staples and had to wear a heart monitor for 14 days. Diagnosis syncope. In 2013, i had been put an iv antibiotics but i had to do myself and home health nurse. I have had pic lines 3 times and had stroke and heart attacks 6 months later. My feet had 9 surgeries, 3 on left foot for pressure ulcer and bone removed (b)(6) 2009. The first pressure ulcer surgery was in right foot (b)(6) 2007, (b)(6) 2010 - 2nd surgery, 3rd surgery in 2012, 4th in 2013, 5th in 2015, and in (b)(6) 2015 removal of 2nd toe on right foot with removal of tissue bone tendon and muscle. Five months later, 2 heart attacks, pneumonia and congestive heart failure diagnosed. Is the product compounded: yes. Is the product over-the-counter: no. How was it taken or used: iv. Dates of use: (b)(6) 2015. Whey was the person using the product: amputated toe (b)(6) 2015. Did the problem return if the person started taking or using the product again: did not start. I have had 3 pic lines put in vena cava, right arm, left arm. Pic line in right leg in (b)(6).
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Brand NamePIC LINE
Type of DevicePIC LINE
MDR Report Key6541267
MDR Text Key74476668
Report NumberMW5069539
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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: 05/01/2017 Patient Sequence Number: 1