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

Catalog Number	5950080
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	12/03/2020
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-mar-2015) is considered to be a best estimate.This emdr represents the bard ventrio st (device 2).An additional supplemental emdr was submitted to represent the bard 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 laparoscopic repair with implant of ventralight st (device 1).Per op notes, ¿the omentum and bowel adhesions were lysed.Two hernia defects were identified and reduced.A ventralight st (device 1) was placed and tacked using sutures.¿ (b)(6) 2015 - patient was diagnosed with incarcerated recurrent ventral hernia with pain thereby underwent laparoscopic repair with excision of ventralight st (device 1) and implant of ventrio st (device 2).Per op notes, ¿large amount of adhesions was lysed.Adhesiolysis and enterolysis were performed.The colon adherent to mesh was lysed.The prior mesh (device 1) was excised.Large hernia sacs were identified and excised.A ventrio st (device 2) was placed and sutured.¿ (b)(6) 2020 - patient was diagnosed with multiple recurrent incarcerated ventral hernia and small bowel obstruction thereby underwent open repair with implant of ventrio st (device 3).Per op notes, ¿large hernia sacs were identified and opened.The loops of small bowel were noted and released.The bowel was reduced.The sac was resected.The bowel adherent to abdominal wall was taken down.A ventrio st (device 3) was placed and tacked using optifix.¿.

• 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: 23035523
• Report Number: 1213643-2025-00830
• Device Sequence Number: 21136529
• Product Code: FTL
• UDI-Device Identifier: 00801741031571
• UDI-Public: (01)00801741031571(17)170328(10)HUZC0214
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 03/28/2017
• Device Catalogue Number: 5950080
• Device Lot Number: HUZC0214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2015
• 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