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

Catalog Number	5950050
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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-dec-2019) is considered to be a best estimate.This emdr represents the bd ventrio st mesh (device 2).An additional supplemental emdr was submitted to represent the bd sepramesh (device 1).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
Addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device 1).Per operative notes, ¿an incision was made in the left upper quadrant in the abdomen.Hernia sac was dissected out.A sepramesh ip (device 1) was placed in the abdominal cavity and secure it with sutures.¿ (b)(6) 2010 - patient was diagnosed with partial small bowel obstruction, adhesions thereby underwent laparoscopic repair with lysis of adhesion, resection of small bowel.(b)(6) 2016 - patient was diagnosed with adhesion, recurrent small bowel obstruction, thereby underwent open repair with lysis of adhesions, removal of foreign body sepramesh ip (device 1) mesh tacks.(b)(6) 2020 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of ventrio st mesh (device 2).Per operative notes, ¿below the old mesh, hernia was there.Hernia sac was dissected out.All adhesions were taken down.A ventrio st mesh (device 2) was placed in space under the peritoneum and secure it with sutures.¿ (b)(6) 2024 - patient was diagnosed with infected mesh, fistula, adhesions thereby underwent open repair with explant of sepramesh ip (device 1) and ventrio st mesh (device 2) and implant one biological mesh.Per operative notes, ¿an incision was made into the abdomen below the umbilicus.Adhesiolysis was done.Fistula was removed.Infected sepramesh ip (device 1) and ventrio st mesh (device 2) was removed from abdomen.A biological mesh was placed and sutured.¿.

• 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 ; 8005566756
• MDR Report Key: 23474165
• Report Number: 1213643-2025-01063
• Device Sequence Number: 10329887
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540(17)211228(10)HUDZ1872
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2025

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: 12/28/2021
• Device Catalogue Number: 5950050
• Device Lot Number: HUDZ1872
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2019
• 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; Disability
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 102 KG