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

Catalog Number 0010205

Device Problems Defective Device (2588); Material Protrusion/Extrusion (2979)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Disability (2371)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol composix kugel(device#1) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.Adhesions is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.Information is limited at this time.Regarding 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¿.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol composix kugel(device #1).An additional emdr was submitted to represent the bard/davol composix kugel(device #2).An additional emdr was submitted to represent the bard/davol composix kugel(device #3).

Event Description

The following was alleged by the patient's attorney: on (b)(6) 2006: the patient underwent repair of ventral hernias.It is alleged that an a composix kuge (device #1), and composix kugel (device #2) , as well as a composix kugel hernia patch size large(device #3), were implanted in patient during this repair.On (b)(6) 2017:the patient underwent surgery to remove the infected composix kugel(device #1, device #2 and device #3).It is alleged that during the surgery, the surgeon noted, "explanted mesh in multiple pieces and a portion of small bowel that was attached to the mesh" and "upper midline wound with exposed mesh that was heaped up and coming out of the wound".The composix kugel (device #1,device #2 and device #3) implanted in the patient failed to reasonably perform as intended.The composix kugel (device #1, device #2 and device #3) caused serious injury and had to be surgically removed via invasive surgery.It is alleged that the patient continues to experience complications related to the composix kugel(device #1, device #2 and device #3) and will likely require additional surgeries to repair the damage from the "defective" product.The composix kugel (device #1, device #2 and device #3) implanted in the patient failed to reasonably perform as intended and allegedly caused serious injury, sustained severe and permanent pain, suffering, anxiety, depression, disability and impairment.

• Brand Name: 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: jan ling ; 100 crossings blvd.; warwick, RI 02886 ; 8015652663
• MDR Report Key: 8210554
• MDR Text Key: 131890564
• Report Number: 1213643-2019-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003323
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0010205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2018
• 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): Required Intervention; Disability