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	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during routine inspection after receiving the goods, the distributor discovered unknown blue filamentous substances inside the transparent inner packaging of the patch.The photo provided and preliminary evaluation of the sample confirms the presence of "foreign" material (thread like, blue in color) inside of the clamshell tray.Further review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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 filamentous substances inside the transparent inner packaging of the patch.The outer packaging was intact, and the inner packaging was properly sealed before opening.
Event or Problem Description
As reported, during routine inspection after receiving the goods, the distributor discovered unknown blue filamentous substances inside the transparent inner packaging of the patch.The outer packaging was intact, and the inner packaging was properly sealed before opening.
Additional Manufacturer Narrative
As reported, during routine inspection after receiving the goods, the distributor discovered unknown blue filamentous substances inside the transparent inner packaging of the patch.The photo provided and preliminary evaluation of the sample confirms the presence of "foreign" material (thread like, blue in color) inside of the clamshell tray.Further review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.The returned sample and photo analysis confirms that there is "foreign" material (blue filament) in the corner of the clamshell tray.Based on sample and manufacturing process evaluation performed, the identified condition is determined to be a manufacturing-generated condition.A notification of non-conformance was provided to 3dmax personnel focusing on cleanliness and product visual inspection acceptance criteria.The warning section of ifu states "the mesh is supplied sterile.Inspect the packaging to be sure it is intact and undamaged prior to use." updated fields: b4, g3, g6, h2, h3, h6, h10.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: 24444420
• Report Number: 1213643-2026-00212
• Device Sequence Number: 10443623
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(11)241223(17)291128(10)HUJZ0941
• 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,Followup
• Report Date (Section B): 02/27/2026

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: Other
• Device Catalogue Number: 0117311
• Device Lot Number: HUJZ0941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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