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

Catalog Number	0010218
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Disability (2371)
Date of Event	02/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention, disability, infection, pain, depression and anxiety; however, no details have been provided.A review of the ifu finds it to be adequate.Information provided by the patient's attorney is limited and review of the ifu does not assist in the identification of the root cause of the patient's alleged post-op complications.No manufacturing issues associated to the reported event were found in the reviewed lot.Dhr review showed all components for the lot met the specifications and there was no rework or other manufacturing abnormalities that may have contributed to this complaint.The product was sterilized per stated specifications.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for repair of an umbilical hernia with a non bard/davol product on or about (b)(6) 2014.The patient underwent surgical mesh removal and repair of a recurrence of the hernia defect on or about (b)(6) 2014.During this procedure the surgeon noted that the "superior aspect of the mesh graft was detached from the fascia" and a ventrio patch was implanted to repair the hernia defect.On or about (b)(6) 2015 the patient underwent surgical mesh removal.During the procedure, the previously placed mesh was infected and noted "copious amounts of thin purulent fluid between the mesh and the ptfe." it is also alleged that the patient had been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, impairment and the device was defective.

• Brand Name: VENTRIO 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: 9732633
• Report Number: 1213643-2020-01465
• Device Sequence Number: 367444
• Product Code: FTL
• UDI-Device Identifier: 00801741016455
• UDI-Public: (01)00801741016455
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• 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): 02/20/2020

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: 10/28/2015
• Device Catalogue Number: 0010218
• Device Lot Number: HUWJ1185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/20/2020
• 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