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

Catalog Number 5959124

Device Problem Insufficient Information (3190)

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

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

As reported this is a patient with a complex medical/surgical history significant for acute biliary pancreatitis, acute respiratory distress syndrome, abscesses, prolonged intubation tracheotomy, cholecystectomy, small bowel resection, surgical washings (7), a partial pancreatectomy (25%) and diagnosed with the presence of a controlled ventral hernia, all occurring in 2012.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Adhesion is a known inherent risk and is identified in the adverse reaction section of the ifu as a possible complication.Regarding infection the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." 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.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.

Event Description

The following was reported to davol: on (b)(6) 2014 - repair of a ventral hernia with the placement of a sepramesh ip.On (b)(6) 2014 - presented with persistent abdominal pain and increased symptomatology.On (b)(6) 2015 - exploratory laparotomy was performed.(results not provided).On (b)(6) 2016 - presented with draining gastro-intestinal, tachycardia and fever.On (b)(6) 2016 - exploratory laparotomy.A frozen abdomen was observed and two perforations in the small intestine in the presence of the mesh adhered to the intestine.The mesh was removed, a surgical washing was performed, the perforations were repaired and a bogata bag was placed.On (b)(6) 2016 - the patient underwent a surgical washing and the placement of a vac system with dehiscence of repair.The patient is currently in the intensive care with an open abdomen.

• Brand Name: SEPRAMESH IP
• 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: 5393032
• MDR Text Key: 36888663
• Report Number: 1213643-2016-00022
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physicist
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 5959124
• Device Lot Number: HUXG1312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• 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: 41 YR
• Patient Weight: 60