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

Catalog Number 0113360

Device Problems Degraded (1153); Material Too Rigid or Stiff (1544)

Patient Problems Bacterial Infection (1735); Fistula (1862); Sepsis (2067)

Event Date 06/02/2014

Event Type  Injury  

Manufacturer Narrative

Based on the information provided and the patient's complex medical history, at this time no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient outcome.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Fistula formation, adhesions, and inflammation are all listed in the adverse reaction section of the ifu as possible complications.Regarding infection the warning section 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.If additional information is obtained, a supplemental 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.

Event Description

The following is based on medical records provided by the patient's attorney: on (b)(6) 2004- the patient was implanted with a bard / davol composix mesh for the repair of a ventral incisional hernia that developed at an old site of an ileostomy duct.On (b)(6) 2014 - the patient developed an enterocutaneous fistula and underwent a laparotomy, lysis of adhesions, small bowel resection, excision of the bard mesh and repair of the ventral hernia with a non bard/davol biologic graft.The fistula was identified in the right lower quadrant and noted to be intermittently associated with the previous mesh hernia repair.The fistula tract and mesh were excised.The bowel contamination was controlled at the site of the fistula and a small bowel resection and an end to end anastomosis were performed.Postoperatively the patient was diagnosed with tachycardia, he was intubated and due to signs of septic shock was moved to the icu.On (b)(6) 2014 - the patient was diagnosed with septic shock secondary to intra-abdominal sepsis and significant intraperitoneal contamination due to an enterotomy.He underwent a laparotomy, lysis of adhesions, resection of the enterotomy site and abdominal wash out with temporary wound closure.On (b)(6) 2014 - the patient underwent a laparotomy, drainage of an abdominal abscess and temporary wound closure.On (b)(6) 2014 - the patient required prolonged mechanical ventilation and underwent a tracheostomy procedure.During preparation it was noted that the patient's abdominal wound incision had stool leaking from it.After the tracheostomy was performed the surgeon performed an emergent laparotomy and noted a small hole in the small bowel at the level of the previous hand-sewn anastomosis, intra-abdominal collections were drained, and a temporary malecot drain was placed.On (b)(6) 2014 - an abdominal ct scan showed the patient had developed a fistula from the abdominal wall down to the peritoneal surface just lateral to the open ventral incision.On (b)(6) 2014 - the patient was transferred to a skilled nursing rehabilitation facility.There was no additional information provided.

• Brand Name: MESH - COMPOSIX
• 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5871267
• MDR Text Key: 51931658
• Report Number: 1213643-2016-00379
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2008
• Device Catalogue Number: 0113360
• Device Lot Number: 43GND132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2003
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR