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

Catalog Number	5950090
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Disability (2371)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The cause of the patient's post operative complications cannot be determined at this time.Adhesions and infection are known inherent risks of hernia repair surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complications.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The patient's attorney has alleged the following: (b)(6) 2016 - the patient underwent repair of abdominal hernia and a bard/davol ventrio st mesh was implanted in the patient during this repair.On (b)(6) 2017 - the patient underwent surgery to explant an infected hernia mesh.During the surgery, a massive infection was found, at the location where the mesh was located and removed.The bottom surface of the mesh was separated from the omentum and portions were densely adhered to the small bowel.Adhesions had to be removed before the mesh could be completely excised.As alleged, the patient continues to experience complications related to the bard/davol ventrio st mesh and that the patient has been injured.Attorney alleges that the patient has sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment and that the ventrio st implanted in the patient was defective.

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8131197
• Report Number: 1213643-2018-04391
• Device Sequence Number: 1579766
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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: 07/28/2016
• Device Catalogue Number: 5950090
• Device Lot Number: HUYG1257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/04/2018
• 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