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U.S. Department of Health and Human Services


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Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Skin Discoloration (2074)
Event Date 10/22/2010
Event Type  Injury  
Event Description
I had a dr that put a sheet of hernia mesh over 4#small 1cm hernias, this was also placed over aortic bifemoral bypass to my legs. I have read that surgeons don't use this sheet mesh over anything under 5m hernias, so my dr cut all 4 of my 1cm hernias into one. I started having a fever 6 days out of the hospital, went to the er because my fever was approx. 102 degrees and the bulb that they put in for me to squeeze looked like dirty pond water with scales floating in it, even though the surgeon was at the er, he didn't want to see me. He just told the dr at er to give me a antibiotic iv and send me home because i had called his office and they told me it was my fault that i didn't make an appointment to f/u, they made me an appt (b)(6) 2010, this was 8 days after mesh was put in. I went to his office and he saw everyone else that was in office then put me in a room and saw where my infection was red on both sides of the 36 staples and you could feel the heat 3" away. Dr. (b)(6) sent me down to admitting to admit myself, instead of him just having someone come up to my room when he put me in, but admitting didn' even know that i was sent down there by him, they had to call him to see what they should do. I woke up with a football sized hole from my breast bone almost to my c-section. I didn't even have a bellybutton anymore. Dr (b)(6) told me that "he tried to debride the mesh to put it back in but couldn't". I had a sponge with a piece of medical tap over it connected to a vac unit. My muscles were gone past rib cage, it was about 3. 5" deep, 7-8" long, and about 4" wide, everything that touched this mesh was gone. I was in shock, every other day the nurses would come in and pull this sponge out, felt like ripping my insides out, and smelled like road kill, this without getting anything for pain until it was over. Spent over 3 weeks in hospital and 7 months of home pain. Had pic line with antibiotics, vac unit and sponge that had to come out every other day, hardly anything for pain. I had to tell my husband that we couldn't have sex after 22 years of marriage.
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Manufacturer (Section D)
MDR Report Key5347323
MDR Text Key35242931
Report NumberMW5058901
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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: 01/02/2016 Patient Sequence Number: 1