MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; SURGICAL MESH

Catalog Number	0117312
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a cut was noted in the 3dmax light mesh while placing it in the inguinal anatomy of the patient.Based on the event as reported and the evaluation of images and video provided, the most probable cause is the mesh became inadvertently damaged while deploying.A review of the manufacturing records was performed and found the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.The instructions-for-use states, "use an appropriately sized trocar to allow mesh to slide down the trocar with minimal force.Grasp either the medial or lateral edge of the mesh, then deploy through the trocar.If grasping the medial edge, direct the trocar to the pubic tubercle.If grasping the lateral edge, direct the trocar laterally.This will facilitate easy placement." 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.
Event or Problem Description
As reported, an unilateral inguinal hernia repair was performed laparoscopically using 3dmax light mesh on (b)(6) 2026.During this procedure, a cut in the 3dmax light mesh was noted while placing it in the inguinal anatomy.It was reported that this cut in the mesh made it more difficult to position the mesh, as the surgeon had to suture defect to close it, which increased the duration of the surgery.There was no patient injury.

• Brand Name: 3DMAX LIGHT
• 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: 24470791
• Report Number: 1213643-2026-00255
• Device Sequence Number: 13345186
• Product Code: FTL
• UDI-Device Identifier: 00801741031045
• UDI-Public: (01)00801741031045(11)241206(17)291128(10)HUJY1610
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0117312
• Device Lot Number: HUJY1610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Male