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	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 3dmax light mesh was separated (torn) from the sealed edge.This was not reported as an out of box condition.The returned sample has been visibly handled as expected from use and is contaminated with blood/body fluids.Visual evaluation of the sample finds that there is a significant tear in the edge seal with a portion of the mesh having separated from the seal.Evaluation shows that a surgical tool or graspers were used during the placement attempt.Based on the event as reported and sample condition, the likely root cause is user/device interface while handling the mesh with graspers while attempting to deploy.No manufacturing anomalies were found.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 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, during a laparoscopic inguinal hernia repair (tapp), 3dmax light mesh was placed in the patient's body using a 12mm trocar on (b)(6) 2025.It was noticed that the mesh was torn from the sealed edge on the side opposite where the forceps were grasping.There was no visible damage to either the inner or outer packaging, and the product box was fully sealed before opening.A new product was used to complete the procedure.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: 23425721
• Report Number: 1213643-2025-01039
• Device Sequence Number: 8242671
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(11)250108(17)291228(10)HUJZ1055
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: HUJZ1055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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