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

Catalog Number	5954450
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2011 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device 1).Per op notes, ¿a recurrent umbilical hernia encountered with incarcerated omentum.An old patch was excised.A piece of ventralight st mesh (device 1) was placed into cover the fascial defect using sorbafix tacks.¿ (note: the old mesh explanted in this procedure was unknown) on (b)(6) 2015 ¿ patient was diagnosed with supraumbilical hernia thereby underwent open repair with the implant of ventralex st mesh (device 2).Per op notes, ¿extensive adhesion confined to anterior abdominal wall along with a small hernia which was located above the umbilicus.A circular ventralex st mesh (device 2) was placed through the hernial sac and secured using tacks.¿ (note: there is mention/visualization of device 1 in this procedure) on (b)(6) 2016 ¿ patient had pain and was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of ventralex st mesh (device 3).Per op notes, ¿the hernia was located slightly on the medial side was dissected away from the surrounding tissue.A circular ventralex st mesh (device 3) was placed below the peritoneum using sutures.¿ (note: there is mention/visualization of device 1, 2 in this procedure) on (b)(6) 2017 ¿ patient was diagnosed with multiple ventral hernia thereby underwent open repair with the implant of ventralight st mesh (device 4).Per op notes, ¿the hernia located in the fascia was isolated.Lysis of adhesion were carried out.Another small hernia was noted in lower part of wound.A ventralight st mesh (device 4) was placed and fixed to fascia using sutures.¿ (note: there is mention/visualization of device 1, 2, 3 in this procedure) on (b)(6) 2018 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent robotic repair with the removal of meshes (device 1, 2, 3, 4) and implant of ventralight st mesh (device 5).Per op notes, ¿extensive adhesions related to previous ventral hernia repairs were taken down.The recurrent hernia appeared to be middle defect in upper abdomen.The mesh had pulled away and adherent to underlying small bowel.The mesh were freed.A piece of ventralight st mesh was placed into middle of defect and secured circumferentially using sutures.¿.
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-jan-2017) is considered to be a best estimate.This mdr represents the bard/davol- ventralight st mesh (device 4).Additional supplemental emdr's were submitted to represent the bard/davol- ventralight st mesh (device 1), ventralex st mesh (device 2), ventralex st mesh (device 3) and ventralight st mesh (device 5).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: 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: 24256331
• Report Number: 1213643-2026-00076
• Device Sequence Number: 9971060
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618(17)181228(10)HUBN0101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 12/28/2018
• Device Catalogue Number: 5954450
• Device Lot Number: HUBN0101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2017
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 114 KG