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

Catalog Number	0117311
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a hole was observed in the 3dmax light mesh after being grasped with forceps.Visual evaluation confirms a small hole present on the mesh near the medial marker as reported.The likely root cause is that the mesh was inadvertently damaged during attempted placement as the reported damage was not present until after the mesh was grasped with forceps.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 1426 units.The instructions-for-use, provided with the device states, "due to its lightweight nature and low profile, 3dmax¿ light mesh does not need to be rolled around the grasper.Use an appropriate 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, a laparoscopic surgery was performed on (b)(6) 2025.During this procedure, when the health professional grasped the 3dmax light mesh "with forceps, a hole opened up." the hole was noted prior to implantation and a new mesh 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: 23777257
• Report Number: 1213643-2025-01182
• Device Sequence Number: 10150292
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(11)250108(17)291228(10)HUJZ0997
• 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): 11/25/2025

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: 0117311
• Device Lot Number: HUJZ0997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/11/2025
• 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