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

Catalog Number	5954460
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/22/2019
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-dec-2017) is considered to be a best estimate.This emdr represents the bard ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the bard mesh - ventralex (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) 2008 - patient was diagnosed with large non-reducible supraumbilical ventral hernia thereby underwent open repair with the implant of ventralex mesh (device 1).Per operative notes, ¿hernia sac was dissected out.A ventralex mesh (device 1) was placed into the subfascial plane supraumbilical region and secure it with sutures.¿ (b)(6) 2018 - patient was diagnosed with ventral epigastric incisional hernia, prior incision was in the same area thereby underwent robotic repair with implant of ventralight st mesh (device 2).Per operative notes, ¿hernia sac was dissected out.A ventralight st mesh (device 2) was placed into the anterior of abdominal wall and secure it with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent incisional epigastric hernia left side of the midline, adhesion, thereby underwent open repair with implant of synthetic mesh and explant of ventralex mesh (device 1) and ventralight st mesh (device 2).Per operative notes, ¿hernia sac was dissected out.Dense omental adhesions were into the anterior wall.Adhesions were taken down.Previously placed meshes were removed partially.The defect appeared laterally and left of the previous mesh.A synthetic mesh was placed and secure it with sutures.¿.

• Brand Name: VENTRALIGHT ST MESH
• 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: 23035785
• Report Number: 1213643-2025-00831
• Device Sequence Number: 18473914
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)191228(10)HUBZ0395
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 12/28/2019
• Device Catalogue Number: 5954460
• Device Lot Number: HUBZ0395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2017
• 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: Male