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

Catalog Number	0117016
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	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon opening the package it was noted that the soft mesh package had a small black item on the mesh.The device was not used and another mesh was opened.There was no patient injury.
Additional Manufacturer Narrative
As reported, upon opening the package it was noted that the soft mesh package had a small black item on the mesh.Preliminary visual examination confirms there is "foreign" material visible on the mesh.The material appears very small and black in color.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.A review of the manufacturing records was performed and found that the lot was manufactured to the 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, upon opening the package it was noted that the soft mesh package had a small black item on the mesh.The device was not used and another mesh was opened.There was no patient injury.
Additional Manufacturer Narrative
As reported, upon opening the package it was noted that the soft mesh package had a small black item on the mesh.Preliminary visual examination confirms there is "foreign" material visible on the mesh.The material appears very small and black in color.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.A review of the manufacturing records was performed and found that the lot was manufactured to the 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.Evaluation of the returned sample and photos confirms that there is "foreign" material visible on the mesh.Based on the sample device evaluation, foreign matter reported on mesh (small black foreign material) was not identified as being part of the components or material used in the manufacturing process.No discrepancies were found either at the cutting process nor the packaging/sealing inspection process that could be related to condition evaluated.How or when the small black material presented on the mesh cannot be determined; however, is mostly likely to have presented after the manufacturing process.Updated fields: b4, d9, 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: BARD SOFT MESH
• 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: 24326888
• Report Number: 1213643-2026-00123
• Device Sequence Number: 18633561
• Product Code: FTL
• UDI-Device Identifier: 00801741030932
• UDI-Public: (01)00801741030932(17)291228(10)HUJZ1298
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2026

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: Health Professional
• Device Catalogue Number: 0117016
• Device Lot Number: HUJZ1298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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