MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED W/ KEYHOLE; SURGICAL MESH

Catalog Number	0113710
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	03/09/2015
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, hernia recurrence, adhesions and subsequent surgical intervention for mesh removal.The instructions-for-use (ifu) supplied with the device lists recurrence of hernia and adhesions 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 mesh pre-shaped w/ keyhole (device #2).Additional emdrs were submitted to represent the bard/davol perfix plug (device #1), the bard mesh pre-shaped w/ keyhole (device #3) and the bard/davol ventrio st (device #4).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient was implanted with 2 bard pre-shaped meshes in course of an umbilical and inguinal hernia repair surgery on (b)(6) 2014.It is alleged that further to the implantation with the product, the patient suffered the development of recurrent left inguinal hernia, pain and swelling in the left groin and external oblique was attached to the underlying mesh.Attorney alleges that the patient underwent revision surgery which required removal of the mesh and placement of alternative mesh to repair the recurring hernia on or about (b)(6) 2015.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 that the patient experienced severe pain and suffering, including chronic pain.It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest.Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care.It is also alleged that the device was defective.Note: the patient was also implanted with a bard/davol perfix plug and a bard/davol ventrio st mesh and a claim of adverse patient outcome has been made against all the devices.

• Brand Name: BARD MESH PRE-SHAPED W/ KEYHOLE
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12322243
• Report Number: 1213643-2021-06882
• Device Sequence Number: 19908910
• Product Code: FTL
• UDI-Device Identifier: 00801741030703
• UDI-Public: (01)00801741030703
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2021

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: 07/28/2019
• Device Catalogue Number: 0113710
• Device Lot Number: HUYF1500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/14/2021
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 35 YR