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

Catalog Number	5950050
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695)
Date of Event	02/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2006 ¿ patient was diagnosed with incarcerated epigastric hernia thereby underwent open repair with implant of composix mesh (device #1).Per operative notes, "the hernia was identified.A small patch of composix mesh (device #1) was placed and sutured." (b)(6) 2013 ¿ patient was diagnosed with ventral hernia and pain thereby underwent open repair with removal of mesh (device #1) and implant of ventrio st mesh (device #2).Per operative notes, ¿the previous composix mesh (device #1) was balled up and pulled away from the wound which caused pain.The previously placed mesh (device #1) was removed.The ventrio st mesh (device#2) was placed and covered all the areas.¿ (b)(6) 2019 ¿ patient was diagnosed with abdominal pain thereby underwent laparoscopic repair with removal of ventrio st mesh (device #2).Per operative notes, ¿the mesh was adhered to the abdominal wall in the area that caused pain.The ventrio st mesh (device #2) was folded slightly and densely incorporated was removed.¿.
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-may-2013) is considered to be a best estimate.This emdr was submitted to represent the bard/davol ventrio st (device #2).Additional supplemental emdr represents the bard/davol mesh - composix (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.

• 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: 22714539
• Report Number: 1213643-2025-00714
• Device Sequence Number: 9132799
• Product Code: FTL
• UDI-Device Identifier: 00801741031540
• UDI-Public: (01)00801741031540(17)150528(10)HUXE0996
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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: 05/28/2015
• Device Catalogue Number: 5950050
• Device Lot Number: HUXE0996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2013
• 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: 48 YR
• Patient Sex: Female