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

Catalog Number	0117310
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the edge of the 3dmax light mesh was torn.Initial evaluation finds the mesh has been visibly handled as expected from use and is contaminate with blood/body fluids.Visual evaluation of the sample finds there is a significant tear in the edge seal with a big portion of the mesh having separated from the seal.There is also a small piece of the seal edge that has completely detached.There is evidence that a surgical tool / graspers was used during placement attempt.Based on the sample condition, the root cause of the reported event is most likely due to the result of user/device interface while handling the mesh with graspers and attempting to deploy.The precautions section in the ifu states, "use an appropriately sized trocar to allow mesh to slide down the trocar with minimal force".A review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4).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, while preparing to insert 3dmax light mesh into the patient, a piece of the edge broke off.It was reported that the mesh was discarded, and another 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: 22292608
• Report Number: 1213643-2025-00502
• Device Sequence Number: 15672309
• Product Code: FTL
• UDI-Device Identifier: 00801741031021
• UDI-Public: (01)00801741031021(11)240905(17)290828(10)HUJV1974
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: 0117310
• Device Lot Number: HUJV1974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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 Sex: Unknown