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

Catalog Number 0010205

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

Patient Problems Adhesion(s) (1695); Inflammation (1932); Disability (2371)

Event Date 04/15/2015

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, adhesions, inflammation and subsequent surgical intervention.The instructions-for-use supplied with the device lists adhesions, inflammation as possible complications.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that on or about (b)(6) 2012, the patient underwent surgery for the repair of an umbilical hernia.A non-bard/davol product was implanted to repair the hernia.It is alleged on (b)(6) 2013, the patient underwent revision surgery and a bard/davol composix kugel mesh was implanted to repair a hernia.It is alleged on or about (b)(6) 2015, the patient underwent further revision surgery and removal of the meshes.It is alleged that the patient has suffered and will continue to suffer severe and chronic pain, inflammation, adhesions, mesh detachment, and surgery to remove the meshes.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient." 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: 11379854
• MDR Text Key: 233697477
• Report Number: 1213643-2021-01307
• 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
• 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: 06/28/2016
• Device Catalogue Number: 0010205
• Device Lot Number: HUVF0085
• 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: 06/27/2011
• 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