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

Catalog Number	5950090
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Unspecified Infection (1930); Injury (2348)
Date of Event	11/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries and subsequent surgery; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges the patient underwent surgery for implant of an unspecified bard/davol ventrio st on (b)(6) 2016.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventrio st.As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries and subsequent surgery; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jul-2016) is considered to be a best estimate.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Attorney alleges the patient underwent surgery for implant of an unspecified bard/davol ventrio st on 10/31/2016.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventrio st.As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per plaintiff profile form and medical records: (b)(6) 2016 - patient was diagnosed with incarcerated ventral incisional hernia thereby underwent open repair with the implant of ventrio st mesh (device #1).Per operative notes, "dense adhesions were noted and taken down.The defect was noted and a ventrio st mesh (device #1) was placed." (b)(6) 2016 - patient was diagnosed with intra-abdominal abscess, enterocutaneous fistula thereby underwent drainage of abscess and removal of infected mesh.Per operative notes, "the mesh (device #1) was seen and removed." (b)(6) 2016 - patient was diagnosed with ventral incisional hernia and enterocutaneous fistula thereby underwent reopening of recent celiotomy and retention suture placement.(b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of phasix st mesh (device #2).Per operative notes, "the defect was noted.A piece of phasix mesh (device #2) was placed deep to the fascia and sutured circumferentially.".

• Brand Name: VENTRIO ST
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 9363941
• Report Number: 1213643-2019-11444
• Device Sequence Number: 2167475
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588(17)180728(10)HUAU0178
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 07/28/2018
• Device Catalogue Number: 5950090
• Device Lot Number: HUAU0178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female