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

Catalog Number 0010202

Device Problems Break (1069); Defective Device (2588); Folded (2630); Material Deformation (2976)

Patient Problems Death (1802); Fistula (1862); Unspecified Infection (1930); Pain (1994)

Event Type  Death  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.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.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 was reported to davol by the patient's attorney: (b)(6) 2004: the patient was implanted with a bard/davol large oval composix kugel hernia patch for a hernia repair.(b)(6) 2014: allegedly the implanted bard/davol composix kugel hernia patch memory recoil ring broke, allegedly causing damage to internal organs, including, enterocutaneous fistula and chronic infection.It was also alleged that further surgery is indicated to remove the bard hernia patch and repair the fistula, however the patient's medical condition would not permit it.It is alleged that as a direct and proximate result of the defects in the bard/davol composix kugel patch, and the injuries which the patch caused, the patient has experienced and will continue to experienced complications including infection, pain and suffering and disability.

Manufacturer Narrative

Device not returned.

Manufacturer Narrative

Addendum to the initial report.Based on a review of medical records, the patient had a complex medical condition and passed away due to infected abdominal mesh following hernia repair surgery with copd having been contributory.Per medical records and pathology there is no report of a separation of the mesh material or a recoil ring break as was originally alleged by the patient's attorney.Pathology report states mesh was, "completely soaked with feces." also states the mesh to be, "all curled up" at that time and has an, "intact rim around it, however the rim is folded." a review of the manufacturing records found no manufacturing related cause for the reported event.With the current information available and the patient's multiple comorbidities, no conclusion can be made as to the degree to which the device may have caused or contributed to the reported post-op complications.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.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: ni/ni/2004 - patient is noted to have undergone three surgeries in a 24 hour period due to a ruptured gangrenous appendix.(b)(6) 2004 - the patient underwent incisional hernia repair with implant of a composix kugel patch.Operative notes indicate the patient to have a "severe adhesive mechanism of the omentum to the anterior abdominal wall as well as the small bowel" resulting from previous surgeries.(b)(6) 2004 and (b)(6) 2004 - patient had postop visits with no significant findings.(b)(6) 2005 - the patient was evaluated for abdominal pain.The patient lost about 40 lbs unintentionally.Patient was reported to be doing "very" well.Pain is only occasional.No evidence of recurrence.(b)(6) 2013 - patient placed on antibiotics for suspected infected mesh.(b)(6) 2015 - follow up visit, it is reported that the patient had not been compliant in taking the antibiotics as prescribed to treat the infection.(b)(6) 2014 - possible infected mesh.Organism unknown.Treated with antibiotics.Per md, "he is not a surgical candidate." patient not willing to quit smoking, despite md advice.(b)(6) 2015 - (b)(6) 2015 - patient was seen multiple times and was treated for infection abdominal mesh.Treated with ostomy.Due to the patient's severe pulmonary disease the md notes he is not a candidate for resection of the mesh.(b)(6) 2015 - patient passed away per forensic pathology report.The cause of death is noted as abdominal infection following hernia repair surgery with copd to have been contributory.This report also states "the manner of death is undeterminable.".

• 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: 5000409
• MDR Text Key: 22856569
• Report Number: 1213643-2015-00277
• 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,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2008
• Device Catalogue Number: 0010202
• Device Lot Number: 43KND418
• 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: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2003
• 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): Death; Required Intervention; Disability
• Patient Weight: 57