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

Catalog Number	5955600
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	09/18/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2015 - patient was diagnosed with incisional ventral hernia thereby underwent laparoscopic repair with implant of ventralight st with echo ps mesh (device 1 and 2).Per op notes, "the hernia defect was identified and cleared from all adhesions.The defect was extending from slightly above the symphysis pubis upwards.The top component of the hernia was made of a swiss cheese defect.A ventralight st with echo ps (device 1) was placed and secured with multiple tacks and intracorporal stitches.The second mesh ventralight st with echo ps (device 2) was placed to cover the swiss cheese defect above the umbilicus.This overlapped with the lower mesh inferiorly and secured with tacks and sutures." on (b)(6) 2015 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair.Per op notes, "a vertical incision was made over the palpable recurrence.The hernia sac was identified.A loop of bowel was stuck in it with some acute adhesions that was separated.Weakened fascia underneath the defect was opened and snaked between two pieces of mesh, both of which were staying in their place but the bowel was went between them.The bowel was then reduced and sutures were placed between the lower mesh and abdominal wall.Then both meshes were attached with suture.The mesh was irrigated and applied tissue glue between parts of the mesh where there was incomplete adherence to abdominal wall and fascia.The hernia sac was removed and the defect was closed with suture.".
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-2014) is considered to be a best estimate.This emdr represents the ventralight st using echo ps (device 2).An additional supplemental emdr was submitted to represent the ventralight st using echo ps (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
• 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: 25648760
• Report Number: 1213643-2026-00798
• Device Sequence Number: 20302904
• Product Code: FTL
• UDI-Device Identifier: 00801741031731
• UDI-Public: (01)00801741031731(17)160528(10)HUYE1067
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K130968
• 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): 06/16/2026

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: 05/28/2016
• Device Catalogue Number: 5955600
• Device Lot Number: HUYE1067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2014
• 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: 45 YR
• Patient Sex: Female