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

Catalog Number	0117311
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, on (b)(6) 2025 the patient underwent a tension-free laparoscopic hernia repair.During the procedure, suspected contaminants (small yellow stains of unknown nature) were found on the sterile inner packaging of the 3dmax light mesh.The product box was confirmed to be fully sealed with no visible damage to the inner or outer packaging.Another mesh was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, during the procedure suspected contaminants (small yellow stains of unknown nature) were found on the sterile inner packaging of the 3dmax light mesh.The sample is said to be available for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of 1,380 units.If/when the sample has been returned and evaluated a supplemental mdr will be submitted to document the results.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.
Additional Manufacturer Narrative
As reported, during the procedure suspected contaminants (small yellow stains of unknown nature) were found on the sterile inner packaging of the 3dmax light mesh.The sample is said to be available for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found the lot was manufactured to the specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.If/when the sample has been returned and evaluated a supplemental mdr will be submitted to document the results.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Based on the sample evaluation conducted, the root cause was confirmed to be manufacturing-related.The reported "yellow stains" on the mesh was identified as excess food-grade lubricating oil from the sewing machine.Awareness was communicated to the appropriate personnel to emphasize the importance of product visual acceptance criteria and the cleanliness of equipment as established under current procedure revision requirements.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.Corrected field: h4.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) 2025 the patient underwent a tension-free laparoscopic hernia repair.During the procedure, suspected contaminants (small yellow stains of unknown nature) were found on the sterile inner packaging of the 3dmax light mesh.The product box was confirmed to be fully sealed with no visible damage to the inner or outer packaging.Another mesh was used to complete the procedure.There was no reported 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: 23248493
• Report Number: 1213643-2025-00940
• Device Sequence Number: 18745344
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(17)290428(10)HUJS1149
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 0117311
• Device Lot Number: HUJS1149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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