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

Catalog Number 0010208

Device Problems Defective Device (2588); Folded (2630)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Bowel Perforation (2668)

Event Date 09/20/2012

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The medical records indicate the patient was treated for infection, adhesions and bowel perforation.Adhesions is listed as a known adverse reaction in the instructions-for-use.If the posiflex monofilament is cut or damage during insertion or fixation, additional known adverse reactions may include bowel or skin perforation and infection.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.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.Not returned to manufacturer.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2004: the patient underwent a ventral incisional hernia repair with implant of a bard/davol composix kugel hernia patch.The implant operative details indicated multiple adhesions were removed prior to suturing the composix kugel patch.(b)(6) 2012: patient presented to the er with complaints of severe abdominal pain, nausea, fever and chills.Patient underwent a laparoscopic appendectomy as well as drainage of abdominal and pelvic abscess.Per the surgeons op report "abdominal and pelvic abscess present, he had a fair amount of scar tissue from a previous laparotomy as well as incisional hernia repair.There certainly is concern that because he had a hernia repair that the mesh could get infected, though it does not appear to be infected today." (b)(6) 2012: the patient returned to the or for an exploratory laparotomy with drainage of abdominal abscess, partial small bowel resection x2, removal of infected mesh and lysis of adhesions.Per the operative notes "a small bowel perforation from where the mesh had peeled down at the left lower quadrant of the abdomen, curled under and actually had grown into the bowel." the memory ring in the composix kugel patch was visualized by the surgeon, however, he could not determine whether the ring had broke or not, he indicated it "appeared to have been intact." (b)(6) 2014: patient underwent implant of a non-bard/davol biologic graft for repair of a recurrent ventral hernia.

• 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: 5083744
• MDR Text Key: 26016178
• Report Number: 1213643-2015-00317
• 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: consumer
• Reporter Occupation: Attorney
• Remedial Action: Other
• Report Date: 08/20/2015

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: 12/31/2008
• Device Catalogue Number: 0010208
• Device Lot Number: 43LND230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2003
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 73