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

Catalog Number	0117321
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the edges of the 3dmax light mesh tore while positioning the mesh in the abdominal cavity.The in-vivo photo confirms the presence of two cracks/tears along the mesh edge seal.However, the photos do not assist in determining root cause.There was no report of the mesh being torn out of the box.Based on the reported event and without having the physical sample to evaluate, no conclusions can be made.The most probable cause is inadvertent damage to mesh while deploying.A review of the manufacturing records was performed and found that the lot was manufactured to the 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, on (b)(6) 2026 during a laparoscopic transabdominal preperitoneal (tapp) inguinal hernia repair, the edges of the 3dmax light mesh tore while the mesh was being positioned within the abdominal cavity.The mesh was implanted in the patient.A 10 mm trocar was used during the procedure.There was no damage observed on either the outer or inner packaging, and the mesh package was fully sealed prior to opening.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, the edges of the 3dmax light mesh tore while positioning the mesh in the abdominal cavity.The in-vivo photo confirms the presence of two cracks/tears along the mesh edge seal.However, the photos do not assist in determining root cause.There was no report of the mesh being torn out of the box.Based on the reported event and without having the physical sample to evaluate, no conclusions can be made.The most probable cause is inadvertent damage to mesh while deploying.A review of the manufacturing records was performed and found that the lot was manufactured to the 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." addendum: h11: this is an addendum to the initial mdr submitted to correct the initial reporter country code.Updated fields: b4, g3, g6, h2, h6, h10, h11.Corrected field: e1 (initial reporter country code).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, on (b)(6) 2026 during a laparoscopic transabdominal preperitoneal (tapp) inguinal hernia repair, the edges of the 3dmax light mesh tore while the mesh was being positioned within the abdominal cavity.The mesh was implanted in the patient.A 10 mm trocar was used during the procedure.There was no damage observed on either the outer or inner packaging, and the mesh package was fully sealed prior to opening.There was no patient harm or 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: 24767424
• Report Number: 1213643-2026-00431
• Device Sequence Number: 18466170
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(11)250108(17)291228(10)HUJZ1006
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 0117321
• Device Lot Number: HUJZ1006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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 Sex: Unknown