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

Catalog Number	0117011
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Deformity/ Disfigurement (2360)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional 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, bowel complications, adhesions, chronic pain and subsequent surgical intervention.The instructions-for-use (ifu) supplied with the device lists adhesions as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the date of event is considered to be a best estimate as (b)(6) 2019 based on the information provided.This emdr represents the bard soft mesh (device #2).An additional emdr was submitted to represent the bard/davol composix kugel (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2004, the patient underwent surgery for an incisional hernia repair and a bard/davol composix kugel hernia patch was implanted.It is alleged that on (b)(6) 2006 and on (b)(6) 2007, the patient underwent revision surgeries.It is also alleged that on (b)(6) 2011, the patient underwent a revision surgery with implant of a bard/davol soft mesh and in (b)(6) 2019 the patient underwent another revision surgery.Attorney alleges that further to implantation with the product, the patient suffered the development of bowel complications, mesh adhesions, abdominal complications and chronic pain.It is alleged that the patient has suffered injuries, losses, and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.Attorney alleges the patient suffered permanent injuries including scarring, disfigurement, suffering and physical disability.It is alleged that the patient continues to undergo medical care and treatment.It is also alleged that the device was defective.

• Brand Name: BARD SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12457956
• Report Number: 1213643-2021-07517
• Device Sequence Number: 4738800
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2015
• Device Catalogue Number: 0117011
• Device Lot Number: HUUE1463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability