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

Catalog Number	0115322
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a bilateral inguinal surgery, the surgeon identified a size mismatch in one of the 3dmax mesh packages.It is alleged that a 3dmax mesh (medium) was inside packaging labeled as 3dmax mesh (extra-large).It is reported that the procedure was completed with the same 3dmax mesh (medium).Reportedly, the product packaging was intact, sealed, and properly labeled with the product details (lot no., catalog no.And expiry date).There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, during a bilateral inguinal surgery, the surgeon noted a potential labeling discrepancy in which a device identified as a 3dmax medium mesh was allegedly contained within packaging labeled as a 3dmax extra-large mesh.The procedure was reportedly completed using the 3dmax medium mesh.Based on the information currently available, and in the absence of photographs or the returned product sample for evaluation, the reported condition cannot be confirmed and no definitive conclusions can be drawn regarding the alleged labeling discrepancy.A review of the manufacturing records confirmed that the subject lot was manufactured in accordance with applicable specifications.To date, this is the only reported complaint associated with this manufacturing lot of 297 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.

• Brand Name: 3DMAX
• 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: 25157121
• Report Number: 1213643-2026-00618
• Device Sequence Number: 9378623
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772(11)250827(17)300728(10)HUKV0522
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: 0115322
• Device Lot Number: HUKV0522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• 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 Age: 72 YR
• Patient Sex: Male