MAUDE Adverse Event Report: BARD/DEVOL COMPOSIX KUGEL HERNIA PATCH, OVAL, 8.7" X 10.7"

Catalog Number REF: 0010206

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Abscess (1690); Bacterial Infection (1735); Fistula (1862); Pain (1994); Hernia (2240)

Event Date 09/03/2015

Event Type  Injury  

Event Description

In (b)(6) 2008 i had a ventral hernia repair performed using a bard composix kugel hernia patch, oval, p/n: 0010206, lot number: hure1011.For the first couple of years i had no problems, but in (b)(6) 2010 i started to have abdominal pain and bowel issues.Since (b)(6) 2010, i have experienced many episodes of abdominal pain and bowel issues.In (b)(6) 2014, and (b)(6) 2015.The episodes of abdominal pain and bowel issues became continuous.On (b)(6) 2015, i was not feeling well again so i went to the doctor who sent me to the hospital.After a sonogram, i was admitted to the hospital with a possible abscess or herniated loop at the bowel through the hernia repair site.On (b)(6) 2015 an emergency surgery was performed to discover the abdominal abscess.The surgery showed an infected abdominal mesh which had to be removed.The polypropylene mesh component had come in contact with the bowel causing injuries to the bowel.This mesh had become part of and had grown into some of my other organs.When the mesh was removed, it caused an intestinal fistula.I was informed by bard/devol that this particular mesh lot number was a re-designed version and not part of the recall.With that being said, i am very concerned that other people who have had surgeries using this mesh product could be experiencing health issues with the mesh attaching to their livers or intestines as it did to me.I felt that it was my responsibility to share this information with the fda so it could become record in case someone else has the same problem or worse.I wish i could have attached the pictures.

• Brand Name: COMPOSIX KUGEL HERNIA PATCH, OVAL, 8.7" X 10.7"
• Type of Device: COMPOSIX KUGEL HERNIA PATCH, OVAL, 8.7" X 10.7"
• Manufacturer (Section D): BARD/DEVOL
• MDR Report Key: 6493060
• MDR Text Key: 72938784
• Report Number: MW5069089
• 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: Other
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: REF: 0010206
• Device Lot Number: HURE1011
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ATIVAN; CALCIUM; OTC MEDS: MULTIVITAMIN; RX MEDS: AMBIEN; VITAMIN C; ZOLOFF.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 70