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

Catalog Number 0113112

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

Patient Problems Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Perforation (2001); Disability (2371); Bowel Perforation (2668)

Event Date 11/06/2014

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.To date no medical records have been provided.Without a lot number a review of the manufacturing records could not be conducted.With the currently available information, no conclusion can be drawn.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 was reported to davol by the patient's attorney: on (b)(6) 1998 - the patient was surgically implanted with a bard composix mesh for repair of hernia.At some point post procedure, the patient experienced intractable and continuing pain.On (b)(6) 2014 - the patient was admitted to the hospital with a large intra-abdominal abscess alleged to have been caused by the bard composix mesh, which had perforated her small intestine.Surgery was performed to remove the mesh and a large section of small intestine was resected.It is alleged by the patient's attorney that the patient experienced significant physical pain and suffering, has sustained permanent injury, and permanent and substantial physical deformity and scarring, has undergone multiple corrective surgeries and is expected to undergo additional corrective surgeries.

Manufacturer Narrative

Addendum to the initial report.This supplemental emdr is being sent.Due to additional information received from medical records provided to davol by the patient's attorney.The medical records provided indicate the patient experienced folded mesh, erosion, fistula, adhesions, pain and infection.Adhesions and fistula are listed as known possible adverse reaction 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.¿ without a lot number a review of the manufacturing records could not be conducted.With the information provided, it is unclear to what extent the composix mesh may have caused or contributed to the problems experienced post implant due to the patient's surgical history of multiple abdominal procedures, patient's medical history and limited medical information provided of the sixteen years between implant and explant of the composix mesh.If additional event and/or evaluation information is obtained, this report will be updated.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 1998 - the patient was diagnosed with a large abdominal incisional hernia, small bowel adhesions and internal herniation with possible small bowel obstruction.The patient underwent an exploratory laparotomy, lysis of adhesions, release of internal herniation and partial small bowel obstruction, removal of an unknown "marlex" mesh, implant of two non-bard davol "seprafilm" and implant of a 12 x 12 inch bard composix mesh.On (b)(6) 2014 - the patient was admitted to the hospital with abdominal pain, nausea and vomiting.A ct scan was performed which showed an abscess just behind the anterior abdominal wall.Mesh could not be seen on the ct scan.The radiologist performed a percutaneous drainage of the abscess which was then cultured and was positive for growth of e.Coli.The patient was treated with iv antibiotics and then transferred to another hospital for surgical management.On (b)(6) 2014 - the patient was diagnosed with an infected composix mesh and probably fistula.The patient underwent an exploratory laparotomy, debridement of skin and subcu tissue, explant of the composix mesh and small bowel resection with primary anastomosis.Per operative details "the mesh (composix) was encountered.This was densely adherent to the overlying abd wall muscle and fascia; flaps were created allowing for dissection of the abd wall off of the underlying mesh (composix).There was one region where the small bowel was densely adherent to the mesh (composix) where it appeared that the mesh had folded over and there was one area where a corner of the mesh appeared to have eroded into the lumen of the small bowel and although an obvious fistula could not be demonstrated at the time of surgery, this was felt to likely be the nidus for the process.Subsequently, this section of small bowel was resected and a primary anastomosis was performed.The mesh was completely explanted as well.

• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6199773
• MDR Text Key: 63132633
• Report Number: 1213643-2016-00589
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0113112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Age: 73 YR
• Patient Weight: 85