MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO MESH; SURGICAL MESH

Catalog Number	0010211
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/16/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported post implant of a bard/davol ventrio mesh, the patient was involved in a car accident and several falls which resulted in the mesh tearing loose.In addition, it was reported that post implant.The patient complained of severe pain which led to an unspecified revision surgery.Based on the available information, it is unclear if the pain and revision surgery occurred prior to, or after the car accident and falls.It was also reported that the patient had recently passed away due to multiple non-device related complications including covid-19, septic shock, and copd.It was reported that the mesh remained implanted at the time of the patient¿s death.No medical records, autopsy report, or death certificate have been provided.Based on the available information, no conclusions can be made.Pain is a known inherent risk of any surgical procedure.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the patient¿s reported postoperative course.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november, 2014.Note, the date of event provided ((b)(6) 2015) is estimated based on the allegation statement of the patient¿s pain post implant.Should additional information be provided, a supplemental mdr will be submitted.
Event or Problem Description
As reported, the patient underwent surgery for implant of a bard/davol ventrio mesh on (b)(6) 2015, but the mesh had torn loose after a car accident and several falls.Post-implant, the patient had repeated complaints of severe pain that led to a revision surgery.As reported, the patient died on (b)(6) 2021 due to covid-19, septic shock, and chronic obstructive pulmonary disease (copd).

• Brand Name: VENTRIO MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11819248
• Report Number: 1213643-2021-20114
• Device Sequence Number: 14330164
• Product Code: FTL
• UDI-Device Identifier: 00801741016387
• UDI-Public: (01)00801741016387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 10/28/2017
• Device Catalogue Number: 0010211
• Device Lot Number: HUYI2010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/13/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR