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

Catalog Number	5954450
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2014 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device 1).Per op notes, "incisional hernia at umbilicus was noted.The defect was large.A ventralight st mesh (device 1) was placed into abdominal cavity and secured to abdominal wall using sorbafix tacks." (b)(6) 2018 - patient was diagnosed with recurrent ventral hernia, intraabdominal adhesions thereby underwent robotic repair with the removal of mesh (device 1) and implant of ventralight st mesh (device 2).Per op notes, "abdominal wall adhesion were lysed.A recurrent ventral hernia was identified with mesh partly covering the hernia defect.The previously placed mesh (device 1) was removed extracorporeally.Left inguinal mesh was noted.A ventralight st mesh (device 2) was placed and secured to anterior abdominal wall using sutures." (b)(6) 2019 - patient was diagnosed with ventral hernia, intraabdominal adhesions thereby underwent open repair.Per op notes, ¿adhesions were noted between the omentum and small bowel to the anterior abdominal wall and lower abdominal wall was lysed.A prior ventral hernia repair was appreciated.A previous mesh (device 2) was partly covering the fascia and rest was within the hernia sac.Sleeve gastrectomy was done.".
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.This emdr represents the ventralight st mesh (device 2).An additional supplemental emdr was submitted to represent the 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.

• 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: 25426096
• Report Number: 1213643-2026-00725
• Device Sequence Number: 12265652
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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 Catalogue Number: 5954450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Male