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

Catalog Number	0010219
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Injury (2348); Disability (2371)
Date of Event	01/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventrio device may have caused or contributed to the reported event.To date no medical records have been provided.The attorney alleges the patient underwent an additional surgery for extreme abdominal pain and to remove the device and adhesions.Adhesion is a known inherent risk of surgery and is listed in the instructions-for-use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2015: the patient underwent repair of a ventral abdominal hernia.A bard/davol ventrio was implanted in the patient during this repair.On (b)(6) 2016: the patient was experiencing extreme abdominal pain and had to undergo surgical intervention to remove the defective mesh, along with adhesions taken down along both sides of the mesh.The attorney alleges the patient continues to experience complications related to the bard mesh and may require additional surgeries.The product implanted in the patient failed to reasonably perform as intended.It caused serious injury and had to be revised via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the product was initially implanted to treat.The patient was caused to suffer severe personal injuries, pain and suffering.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability and impairment.

• Brand Name: VENTRIO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7883436
• Report Number: 1213643-2018-03154
• Device Sequence Number: 2726448
• Product Code: FTL
• UDI-Device Identifier: 00801741016462
• UDI-Public: (01)00801741016462
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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: 06/28/2017
• Device Catalogue Number: 0010219
• Device Lot Number: HUYF1415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/17/2018
• 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