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); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
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 disability, pain and hospitalization.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the bard/davol ventrio st mesh (device #2).An additional emdr was submitted to represent the bard/davol ventrio st mesh (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) 2017, the patient underwent surgery for the repair of two incisional hernias.A bard/davol ventrio st was implanted to repair the hernia defect.It is alleged that the patient underwent an additional operation to repair and/or remove the defected mesh on or about (b)(6) 2018.Further, another bard/davol ventrio st mesh was implanted.The patient injured severely and permanently.Attorney also alleges that the patient has suffered and will continue to suffer chronic physical pain, disability, hospitalizations, additional surgeries, has undergone and will likely require in the further other forms of care and medical treatments.Attorney also alleges that the device 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: 11995430
• Report Number: 1213643-2021-04710
• Device Sequence Number: 16355124
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2021

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: 12/28/2019
• Device Catalogue Number: 5950090
• Device Lot Number: HUBX2202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/14/2021
• 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; Disability