MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - COMPOSIX KUGEL; SURGICAL MESH

Catalog Number 0010202

Device Problems Defective Device (2588); Folded (2630); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Disability (2371)

Event Type  Injury  

Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2004 - the patient underwent a right inguinal hernia repair using bard mesh, identified as bard composix kugel.After placement, the mesh allegedly caused personal injury.Legal claim alleges that as a result of the implantation of the hernia mesh product the patient suffered and will continue to suffer serious bodily injuries, including pain, discomfort, scarring, infection, and explant/or revision surgery.Patient is also alleged to have experienced "pain and suffering," sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures.

Manufacturer Narrative

No conclusions can be made at this time.Medical records have been requested from the patient's attorney but have not been provided to date.A manufacturing review was performed and found product was made to specification.Based on the product code and lot number the subject product is part of the composix kugel recall initiated on december 2005.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.

Manufacturer Narrative

Addendum to the initial report.Per medical records, the patient underwent additional medical treatment and surgical procedures including explant of the bard/davol composix kugel hernia patch approximately ten years post implant.The patient was found to suffer from adhesions, fistula and infection.Adhesions and fistula are listed as possible adverse reactions in the instructions-for-use.In regards to infection, the warning section of the instructions-for-use states ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ based on the information received, there is no conclusions that can be made at this time.Patient had multiple procedures prior to the explant of the bard/davol composix kugel patch.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

The following is based on a review of the patient's medical records provided to davol by the patient's attorney: on (b)(6) 2004 - the patient underwent implant of a bard/davol composix kugel hernia patch.On (b)(6) 2004 - patient went to the er for incisional bleeding that would not stop and received eight additional skin suture and a new absorption binder.On (b)(6) 2005 - (b)(6) 2011 - patient had two colonoscopies and a total thyroidectomy procedure with no mention or visualization of the composix kugel hernia patch.On (b)(6) 2013 - patient presented with er with complaints of abdominal pain and bloating.An abdominal x-ray showed cholelithiasis, diffuse fatty infiltration of the liver and a right renal with no finding pertaining to the composix kugel hernia patch.Patient had a gallstone and a renal cyst which was believed to be causing her pain.On (b)(6) 2013 - patient had a ct scan performed of her abdominal which indicated she had a possible colitis related to inflammatory bowel disease or infection and the inflammation extends to and involves the abdominal wall.On (b)(6) 2013 - patient went to the hospital er with complaints of an ulceration of the upper portion of her incision that was draining a bloody discharge.While hospitalized the patient underwent an incision and drainage procedure at bedside removing some necrotic tissue and serosanguinous debris.The patient was diagnosed with panniculitis, abscess of the inferior abd wall, cellulitis and then referred to a wound care clinic for wound vac dressing changes.On (b)(6) 2013 - patient had a wound vac placed per the wound is deep with sinus tract formation.On (b)(6) 2013 - patient complained of wound with increased drainage and foul odor.Per md assessment, patient has a chronic draining sinus tract on the anterior abdominal wall in the intertriginous fold with underlying mesh.Md ¿concerned about mesh-associated infection.¿ on (b)(6) 2013 - per md impression: "deep wound infection with suspected infected mesh.Since the mesh has been in for 9 years, it must be extensively incorporated so surgery would be a daunting task.Trying to curb the infection and possibly keep her on chronic suppressive therapies to avoid surgery.Picc line has been placed previously for iv antibiotics." on (b)(6) 2013 - patient underwent debridement of an abdominal wall abscess with a partial explant of the bard/davol composix kugel mesh patch.On (b)(6) 2013 - (b)(6) 2013 - patient had multiple md consultation at an outpatient wound clinic to manage the treatment of her wound vac dressings.On (b)(6) 2014 - patient was diagnosed with infected abdominal wall hernia mesh and underwent total explant of the bard/davol composix kugel hernia patch.Per operative details, "mesh was rolled over, it was noted to have a fair amount of small bowel adherent to the mesh.".

• Brand Name: MESH - COMPOSIX KUGEL
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 4943808
• MDR Text Key: 6250676
• Report Number: 1213643-2015-00256
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K003323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2008
• Device Catalogue Number: 0010202
• Device Lot Number: 43END305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/15/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0760-06
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 127