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

Catalog Number 0010202

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)

Event Date 01/17/2006

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesions, inflammation, chronic pain, mesh detachment and surgical intervention due to the hernia mesh device.The instructions-for-use supplied with the device lists hernia recurrence, adhesions, and inflammation as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the bard/davol mesh - composix kugel (device #1).An additional emdr was submitted to represent the bard/davol mesh - composix kugel (device #2).Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that on (b)(6) 2005, the patient had a large oval bard/davol composix kugel mesh implanted to repair a hernia defect.It is alleged that on or about (b)(6) 2006, the patient underwent surgery to revise the initial kugel mesh and a second bard/davol composix kugel mesh, medium was implanted to repair a recurrent hernia defect.On or about (b)(6) 2008, the patient underwent removal surgery of the kugel meshes and a non-bard/davol product was implanted during this procedure.Attorney alleges that the patient underwent additional revision surgery on (b)(6) 2008 and removal surgeries of one of the mesh products on (b)(6) 2008, (b)(6) 2009 and (b)(6) 20012.Attorney alleges that the patient has suffered and will continue to suffer severe and chronic physical pain, mental anguish, multiple surgeries to remove mesh, scarring, dense adhesions, adhesions to small bowel, mobile or detached mesh, abdominal wall reconstruction, inflammation, and recurrence.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the device was defective.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 11377573
• MDR Text Key: 233532226
• Report Number: 1213643-2021-01210
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2010
• Device Catalogue Number: 0010202
• Device Lot Number: 43CPD327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2005
• 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): Required Intervention; Disability