MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Ventralight ST w/ Echo 2; Surgical Mesh

Catalog Number	5990015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Addendum per additional information provided: (b)(6) 2018 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with implant of ventralight st with echo 2 (device 1 and 2).Per op notes, "there was significant abdominal adhesions to the midline were taken down.All the adhesions between the small bowel, colon and omentum to the multiple large midline hernias throughout the entire incision was taken down.The hernias were reduced.Two separate pieces of ventralight st with echo 2 (device 1 and 2) were placed to cover the defect and sutured." (b)(6) 2020 - patient was diagnosed with recurrent incarcerated incisional hernia with abdominal pain thereby underwent laparoscopic repair with implant of ventralight st with echo 2 (device 3).Per op notes, "dense intra-abdominal adhesions of the small bowel to the anterior abdominal wall and the previously placed mesh (device 1 and 2) were taken down.All the adhesions were taken down.There are multiple hernias along the abdominal wall.The old meshes (device 1 and 2) were seen densely incorporated into abdominal wall.No attempt was made to remove the old mesh.A ventralight st with echo 2 (device 3) was placed and tacked using sorbafix tacker.".
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-2018) is considered to be a best estimate.This emdr represents the ventralight st with echo 2 (device 2).An additional supplemental emdr was submitted to represent the ventralight st with echo 2 (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: Ventralight ST w/ Echo 2
• 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: 50798269
• Report Number: 1213643-2026-01205
• Device Sequence Number: 21485281
• Product Code: FTL
• UDI-Device Identifier: 00801741130991
• UDI-Public: (01)00801741130991(17)190628(10)HUCS0546
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 06/28/2019
• Device Catalogue Number: 5990015
• Device Lot Number: HUCS0546
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2018
• 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