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

Catalog Number 0010202

Device Problems Defective Device (2588); Material Deformation (2976); Insufficient Information (3190)

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

Event Date 04/06/2011

Event Type  Injury  

Manufacturer Narrative

No conclusions can be made.The patient's attorney alleges adverse patient outcomes associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesions and surgical intervention.The instructions-for-use supplied with the device lists adhesions and hernia recurrence as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.

Event Description

Attorney alleges that on or about (b)(6) 2008, the patient underwent surgery for repair of an incisional hernia.A composix kugel patch was implanted to repair the hernia defect.It is alleged that on or about (b)(6) 2011, the patient underwent additional surgery to repair a massive ventral hernia during this procedure the composix kugel patch was found to be bunched up and it was found that the patient's small intestine had become imbedded to the undersurface of the mesh.The composix kugel patch was partially dissected and a non-bard davol mesh was implanted to repair the defect.It is alleged that the patient was injured severely and permanently.The patient suffered pain, disability, hospitalizations and additional surgeries.It is also alleged that the patient has suffered and will continue to suffer physical pain, chronic pain, mental anguish, psychological stress, depression, has undergone and will likely require medical treatments and other forms of care.Attorney also alleges 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: 10686770
• MDR Text Key: 211725687
• Report Number: 1213643-2020-09467
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2012
• Device Catalogue Number: 0010202
• Device Lot Number: HURD2717
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2007
• 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; Required Intervention; Disability