MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955810
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	11/21/2019
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, surgical intervention, infection and hernia recurrence.The instructions-for-use supplied with the device lists hernia recurrence, adhesions, infection and inflammation as possible complications.In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the prosthesis." no lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st w/echo (device #1).An additional emdr was submitted to represent the bard/davol phasix mesh (device #2).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on or about (b)(6) 2014, the patient was implanted with a non-bard davol mesh to repair an umbilical hernia.On or about (b)(6) 2015, the patient underwent an additional surgery; a bard/davol ventralight st w/echo positioning system was implanted in an attempt to repair the recurrent ventral hernia defect.Upon entering the abdomen, the surgeon noted there was a recurrent hernia defect with incarcerated omentum.Adhesions were taken down.On or about (b)(6) 2019, the patient underwent surgery to remove the infected mesh and a bard/davol phasix was implanted in an attempt to repair the recurrent ventral hernias.Upon entering the abdomen, the surgeon noted the presence of a complex partial bowel obstruction.The mesh had become matted to the small bowel and omentum.Extensive adhesions were lysed and the complex partial small bowel obstruction was released.The infected mesh was removed.It is alleged that the mesh products caused serious injury and had to be removed via invasive surgery.Attorney alleges that the patient experienced and/or continues to experience pain, inflammation, nausea, vomiting, diarrhea, chills, loss of appetite, severe pain and suffering, which have impaired plaintiff¿s activities of daily living.It also alleged that the patient is at a higher risk of severe complications during an abdominal surgery, to the extent that future abdominal operations might not be feasible.Attorney also alleges past, present, and future damages, physical disability, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient.It is further alleged that the patient experienced mental anguish, emotional distress and also that the device was defective.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10456820
• Report Number: 1213643-2020-07711
• Device Sequence Number: 14443160
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5955810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/26/2020
• 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