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

Catalog Number	5950040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Seroma (2069)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2007 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with implant of perfix plug (device 1).Per operative notes, ¿in the infraumbilical area, the hernia sac in umbilicus was freed and excised circumferentially.An extra-large perfix plug (device 1) was placed in the hernia defect and secured with sutures in circumferential fashion around the umbilicus.The wound was irrigated and subcutaneous tissues were approximated using sutures.¿ on (b)(6) 2014 ¿ patient was diagnosed with recurrent abdominal wall hernia thereby underwent open repair with implant of ventralex st mesh (device 2).Per operative notes, ¿the hernia right to the umbilicus was noted.The prior umbilical repair with mesh (device 1) was noted and hernia was dissected free and reduced into preperitoneal space.The prior old mesh (device 1) was noted and left in-situ.A medium round ventralex st mesh (device 1) was placed in preperitoneal space and secured it with sutures.The wound was irrigated and closed with sutures.¿ on (b)(6) 2020 ¿ patient was diagnosed with recurrent ventral hernia with pain thereby underwent robotic assisted laparoscopic repair with removal of prior meshes (device 1 and 2) and implant of ventrio st mesh (device 3).Per operative notes, ¿an omentum incarcerated into the hernia defect was noted.The recurrent hernia superior to mesh (device 2) and inferior to mesh (device 1) was noted.The defect superior and inferior to the old meshes (device 1 and 2) were reduced.The old meshes (device 1 and 2) were removed and exited out of the abdominal cavity.The fascial defect was reapproximated with sutures and a piece of ventrio st mesh (device 3) was placed into the abdominal cavity and secured in place with sutures.The mesh (device 3) was secured in place circumferentially and wounds were irrigated.¿ on (b)(6) 2020 ¿ patient had seroma and hematoma thereby underwent repair.Per progress note, ¿patient return with persistent swelling in the prior operative site.On examination, it consistent with a seroma was drained.Approximately 60 cc of old blood was evacuated.The retained hematoma was noted but not drained and left in-situ.
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.This mdr represents the ventrio st (device 3).An additional supplemental emdr was submitted to represent the ventralex st (device 2).An additional emdr was created in gcs to represent the perfix plug (device 1).Note, the manufacturing date (15-feb-2020) is considered to be a best estimate.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: 25109859
• Report Number: 1213643-2026-00597
• Device Sequence Number: 9322295
• Product Code: FTL
• UDI-Device Identifier: 00801741031533
• UDI-Public: (01)00801741031533(17)220228(10)HUEP1345
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 02/28/2022
• Device Catalogue Number: 5950040
• Device Lot Number: HUEP1345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2020
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 94 KG