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

Catalog Number	0117321
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	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a routine inspection after receiving the goods, the distributor discovered unknown blue filamentous substances inside the transparent inner packaging of two 3dmax light mesh (device #1 and device #2) boxes.This file represents device #2.
Additional Manufacturer Narrative
As reported, during a routine inspection after receiving the goods, the distributor discovered unknown blue filamentous substances inside the transparent inner packaging of 3dmax light mesh.Photo and visual examination confirms there is "foreign" material (thread like, blue in color).The material is visible on the mesh.Based on sample and manufacturing process evaluation performed, returned sample condition is determined to be a manufacturing-generated condition.Awareness notification was provided to all appropriate manufacturing personnel.A review of manufacturing records was conducted and shows the product was manufactured to specification.This mdr represents the device #2.An additional mdr was submitted to represent the device #1.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.

• 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: 23832113
• Report Number: 1213643-2025-01239
• Device Sequence Number: 18381269
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(11)241011(17)290928(10)HUJX0168
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: 0117321
• Device Lot Number: HUJX0168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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