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	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during routine inspection upon receipt of goods, the distributor discovered unknown blue filament material inside the inner packaging of a 3dmax light mesh.The photo provided confirms the presence of foreign material (blue filament) within the clamshell tray; however, the photo review does not assist in determining the root cause.The subject mesh was not available for evaluation.Based on the information available and without a sample for analysis, a definitive root cause could not be established.Review of manufacturing records confirms that the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.This mdr represents the 3dmax light (device 3).Additional mdrs were submitted to represent the 3dmax (device 1) and 3dmax light (device 2).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 routine inspection after receiving the goods, the distributor discovered unknown blue filament substances inside the inner packaging of a 3dmax mesh (device 1) and two 3dmax light mesh (device 2 & 3).It was reported that, the outer packaging was intact, and the inner packaging was properly sealed before opening.This file represents device 3.

• 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: 23880410
• Report Number: 1213643-2025-01256
• Device Sequence Number: 4706885
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(11)241018(17)290928(10)HUJX1043
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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: HUJX1043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2024
• 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