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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL BARD MESH DART

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DAVOL BARD MESH DART Back to Search Results
Catalog Number 0112730
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Bacterial Infection (1735); Pain (1994); Hernia (2240); Discomfort (2330); Sweating (2444); Hematuria (2558)
Event Date 08/01/2015
Event Type  Injury  
Event Description
I had a small umbilical hernia that i noticed in (b)(6) 2007. My primary care sent me to a surgeon, dr. (b)(6). Although very small i was told surgery was needed. It was scheduled for early (b)(6) 2008 and performed on (b)(6) 2008. According to the surgeon my hernia was actually larger than appeared and stated he found another hernia while repairing the scheduled one. I don't recall any pain or discomfort in the upper area where the,". Small epigastric hernia which contained a small amount of fat", was found. I only find one "sticker" that shows a davol bard mesh dart, small, monofilament knitted polypropylene", size: small dart, ref 0112730 lot 43aod015, that was used for the repair or repairs. I find no scars or repair indication above the umbilical repair no where. No discomfort after surgery in the upper area at all, extreme pain in recovery around my bellybutton and inner intestinal area. I was literally screaming in pain. Approximately 7 years later i started having discomfort in the whole intestinal area and my primary care started testing to see what could be wrong. We didn't suspect another hernia. My doctor, (b)(6) thought maybe gall stones. After many tests over approximately two years, still no answers but pain has increased and pretty much bed ridden for the last 9-10 months. I have had scope through my penis at a urologist due to blood in my urine, ct scan for possible prostate issues, physical prostate exam, ct scan with dye, and a diagnosis of rapid gastric emptying also known as dumping syndrome and another intestinal issue that causes some food or liquid intake to remain in an area of intestines instead of going with the rest. There was a bacterial test also that came back positive. I have had blood in my urine for almost two years now, it hurts to urinate, sometimes severely, and blood has shown in my stools on occasion during the last few years. Everything points to complications from the hernia surgery which i recently learned about and see that i have almost all of the side effects including nightly drenching sweats. I believe i have some type of mesh migration. Nothing else has pinpointed my symptoms or come close. I can't deal with the pain much longer and need a surgeon who is experienced in this area. So i believe the davol bard mesh is the issue and should be recalled before anyone else has to endure what i'm going through. I need help bad!.
 
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Brand NameBARD MESH DART
Type of DeviceBARD MESH DART
Manufacturer (Section D)
DAVOL
MDR Report Key6557015
MDR Text Key74934800
Report NumberMW5069673
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 05/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0112730
Device Lot Number43AOD015
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: 05/08/2017 Patient Sequence Number: 1
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