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	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, when the 3dmax light mesh was removed from its packaging, the mesh was in perfect condition.After the mesh was inserted through the 10mm trocar, it was observed that the thermo-sealed edges of the mesh were cracked, and on one side, the edge was detached from the rest of the mesh.Provided images of the mesh in vivo show there is a tear visible in the seal edge that separates the seal edge from the mesh.An additional photo shows the mesh after being removed from the patient and decontaminated.The photo shows evidence of the mesh having been rolled/handled during use and again shows a tear present at the bottom of the mesh that separates the seal edge from the mesh completely.Note the mesh is separated from the edge seal not detached.Based on the event as reported and review of the photos provided, the likely root cause is user/device interface while handling the mesh during deployment and attempted placement.The instructions-for-use (ifu), provided with the device 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." 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.Note, the sample is reported to be available for evaluation; however, at this time has not been returned.If/when the sample is returned a supplemental mdr will be submitted to document the physical evaluation.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 right inguinal hernia repair procedure, after the 3dmax light mesh was inserted through a 10 mm trocar, it was observed that the thermo-sealed edges of the mesh were cracked, and on one side the edge was detached from the rest of the mesh.The mesh was removed, and another mesh was used to complete the procedure.Reportedly, no damage was observed to the box, seals, or inner packaging upon transfer to the table.Upon opening the mesh on the table, it was found to be in perfect condition.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: 25123343
• Report Number: 1213643-2026-00603
• Device Sequence Number: 10694780
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(11)250512(17)300428(10)HUKS0150
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: HUKS0150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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 Age: 55 YR
• Patient Sex: Female