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); Necrosis (1971); Pain (1994); Hernia (2240); Fibrosis (3167)
Date of Event	01/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2012 - patient was diagnosed with bilateral ventral hernia thereby underwent laparoscopic repair with implant of ventralight st mesh (device 1 and 2).Per op notes, "the subcoastal incision was made.Two lateral ventral wall hernias were identified and consistent with spigelian hernias.No evidence of inguinal defect was noted.The hernia sacs were removed.A ventralight st mesh (device 1) was placed on right and ventralight st mesh (device 2) was placed on left side of the abdomen and tacked." on (b)(6) 2013 - patient was diagnosed with spigelian hernia thereby underwent open repair with excision of ventralight st mesh (device 1).Per op notes, "a pfannenstiel incision was made.The fascia was cleared to the umbilicus.The midline was opened and adhesions to the prior meshes were taken down.Hernia was not identified but rather an eventration of the mesh on the right side (device 1) was noted.The mesh on the left (device 2) was left in place.The mesh on the right (device 1) was removed, and the defect was closed with suture." on (b)(6) 2016 - patient was diagnosed with recurrent left lower quadrant incisional hernia thereby underwent laparoscopic repair.Per op notes, "an incision was made.Adhesions were taken down with a couple of stitches along the lower abdominal wall midline as well as right lower quadrant and left lower quadrant.Some mesh was noted to be grown into the peritoneum with the omental adhesions removed from this line.Some defect in the mesh along the left abdominal wall above the inguinal area consistent with incisional hernia or weakness of the wall with a little bit of bulging on the left side noted with pneumoperitoneum.Left lower quadrant incisional weakness was noted with some mesh along both sides and repaired with sutures.A little bit of an implant noted to be running along the peritoneum and it was removed from along near the cecum.".
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-sep-2012) is considered to be a best estimate.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: 25704652
• Report Number: 1213643-2026-00851
• Device Sequence Number: 9687653
• Product Code: FTL
• UDI-Device Identifier: 00801741031625
• UDI-Public: (01)00801741031625(17)140928(10)HUWI1165
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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 Expiration Date: 09/28/2014
• Device Catalogue Number: 5954460
• Device Lot Number: HUWI1165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2012
• 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: 37 YR
• Patient Sex: Female