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

Catalog Number	0117320
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, on (b)(6) 2026 during a procedure when the 3dmax light package was opened the mesh fell out due to a defect in the inner seal of the mesh packaging.Reportedly, another mesh was used to complete the procedure.There was no patient contact with the mesh.
Additional Manufacturer Narrative
As reported, during a procedure when the 3dmax light package was opened the mesh fell out "due to a defect in the inner seal of the mesh packaging." evaluation of the returned sample finds the tyvek pouch to be open as received at the chevron end.Inspection of the entire pouch and sealing area confirmed that the pouch was properly sealed and its integrity was intact.The most probable root cause is the tyvek pouch was manually opened at some point after distribution likely at the user facility.No manufacturing anomalies were found.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 released for distribution.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: 25473280
• Report Number: 1213643-2026-00741
• Device Sequence Number: 10307146
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052(11)250213(17)300128(10)HUKP0705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: 0117320
• Device Lot Number: HUKP0705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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