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

Catalog Number	5950070
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Seroma (2069); Hernia (2240)
Date of Event	12/09/2018
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-jun-2017) is considered to be a best estimate.This mdr represents the ventrio st mesh (device 2).An additional supplemental emdr was submitted to represent the ventrio 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) 2018 - patient was diagnosed with incarcerated incisional hernia, adhesions thereby underwent open repair with implant of ventrio st mesh (device 1 and device 2).Per operative notes, ¿a midline incision was made from just above the umbilicus.There were adhesions into the abdominal wall which were dissected out.Two ventrio st mesh (device 1 and device 2) was placed together for better coverage and closed with sutures.¿ (b)(6) 2018 - patient was diagnosed with incarcerated recurrent ventral hernia, scar tissue, thereby underwent open primary hernia repair, resection of portion of small bowel, abdominal washout.Per operative notes, ¿an incision was made through previous incision.Prior scar tissues were removed.Previously placed ventrio st mesh (device 1 and device 2) had incorporated into the fascia.Wound was irrigated and vac placement was done.¿ (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia, seroma thereby underwent open primary hernia repair.Per operative notes, ¿a midline incision was made over the previous scar.The ventral hernia sac was dissected out.Dense amount of serosal fluid was present into the abdominal wall, which was drained entirely.Some previously placed sutures were removed, and primary hernia repair was done.The defect was closed with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia, adhesion, thereby underwent open repair with implant of phasix st mesh (device 3).Per operative notes, ¿an incision was made through previous incision.There was dense number of adhesions which were removed from abdominal wall.Lysis of adhesions were performed.A phasix st mesh (device 3) was placed into the abdominal wall and secure it with sutures.¿.

• 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: 24485034
• Report Number: 1213643-2026-00264
• Device Sequence Number: 5104532
• Product Code: FTL
• UDI-Device Identifier: 00801741031564
• UDI-Public: (01)00801741031564(17)190728(10)HUBT0315
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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: 07/28/2019
• Device Catalogue Number: 5950070
• Device Lot Number: HUBT0315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2017
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 103 KG