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

Catalog Number	1190500
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Disability (2371)
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, pain and inflammation.The instructions-for-use supplied with the device lists inflammation as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the bard/davol phasix mesh (device #2).An additional emdr was submitted to represent the bard/davol ventralight st w/echo (device #1).Should additional information be provided a supplemental emdr will be submitted.
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: PHASIX 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: 10456825
• Report Number: 1213643-2020-07712
• Device Sequence Number: 3960603
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 1190500
• Device Lot Number: HUDT2114
• 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: Disability