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

Catalog Number	5950090
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	06/22/2018
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-oct-2015) is considered to be a best estimate.This mdr represents the ventrio st mesh (device 3).An additional mdr was submitted to represent the phasix mesh (device 2).An additional supplemental emdr was submitted to represent the ventralight st mesh (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
Per information provided: (b)(6) 2014 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of ventralight st mesh (device 1) and a phasix mesh (device 2).Per op notes, "an unknown mesh was removed.A ventralight st mesh (device 1) was placed to cooper's ligament and secured inside the fascia of the rectus muscles down into the pelvis.In the abdominal wall placed a phasix mesh (device 2) to the fascia." (b)(6) 2016 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with removal of mesh (device 1 and 2) and implant of ventrio st mesh (device 3).Per op notes, "severe adhesions noted.The old mesh was attached to the fascia, and the mesh was split in half.Once this was done, removed a piece of the mesh (device 1 and 2).A ventrio st mesh (device 3) was placed to the suprapubic and cooper's ligament on both sides." (b)(6) 2018 - patient had right lower quadrant pain thereby underwent repair with the removal of mesh (device 3) and implant of phasix st mesh (device 4) and adhesiolysis.Per op notes, "adhesions were severe.Detached the mesh (device 3) from the small bowel.Pubis, cooper's ligament and the iliac bone were dissected.A phasix st mesh (device 4) was placed to the pubic bone.".

• 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: 24266055
• Report Number: 1213643-2026-00082
• Device Sequence Number: 10020979
• Product Code: FTL
• UDI-Device Identifier: 00801741031588
• UDI-Public: (01)00801741031588(17)171228(10)HUZJ0284
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: 12/28/2017
• Device Catalogue Number: 5950090
• Device Lot Number: HUZJ0284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2015
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 73 KG