MAUDE Adverse Event Report: DAVOL BARD MESH DART

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!.

• Brand Name: BARD MESH DART
• Type of Device: BARD MESH DART
• Manufacturer (Section D): DAVOL
• MDR Report Key: 6557015
• MDR Text Key: 74934800
• Report Number: MW5069673
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0112730
• Device Lot Number: 43AOD015
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 58 YR
• Patient Weight: 147