MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventrio ST; Surgical Mesh

Catalog Number	5950060
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2012 - patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of ventralex st (device 1).Per op notes, "a incision was made in the area of hernia to the fascia.The hernia sac was identified and the contents were reduced.Adhesions were taken down to free up the preperitoneal space.A ventralex st (device 1) was placed in the preperitoneal space and sutured." (b)(6)2017 - patient was diagnosed with recurrent incarcerated umbilical hernia and abdominal pain thereby underwent open repair with excision of ventralex st (device 1) and implant of ventrio st (device 2).Per op notes, "a midline incision was made below the umbilicus.The fascia was incised and fat was lifted up.The hernia defect was noted superior to the incision, the old mesh (device 1) was noted.Adhesions were lysed.The umbilicus was excised and removed.The hernia sac was opened, and the prior mesh (device 1) was excised and removed entirely.The hernia contents were released.A ventrio st (device 2) was placed and sutured." (b)(6)2017 - patient was diagnosed with wound dehiscence thereby underwent open repair.Per op notes, "the staples from the prior surgery were removed.The dehisced tissue and pannus were excised.Necrotic fat was also excised.The wound was irrigated and wound vac was placed." (b)(6)2019 - patient had small bowel obstruction and adhesions.
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-2016) is considered to be a best estimate.This emdr represents the ventrio st (device 2).An additional supplemental emdr was submitted to represent the ventralex st (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 ; +1(800)556-6756
• MDR Report Key: 50582079
• Report Number: 1213643-2026-01147
• Device Sequence Number: 10196669
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557(17)180628(10)HUAS2124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 06/28/2018
• Device Catalogue Number: 5950060
• Device Lot Number: HUAS2124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2016
• 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 Sex: Female