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

Catalog Number	0115320
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, on (b)(6) 2025 the patient underwent laparoscopic repair (tep technique) of bilateral inguinal hernias.As reported a 3dmax mesh was used for the right sided repair and the surgeon fixated the mesh.Reportedly, "the mesh migrated and it appears the patient may have an early recurrence." the patient's condition is stable; however, the surgeon is planning a revision procedure.The surgeon reports he is a first time user to the 3dmax mesh and was unsure whether the issue was technique or mesh related.
Additional Manufacturer Narrative
As reported, the patient had abdominal mesh migration and hernia recurrence post implant of 3dmax mesh.Based on the information reported, no conclusions can be made as to the degree to which the 3dmax mesh implant used to treat the patient, may have caused, or contributed to the reported hernia recurrence and mesh displacement.The implanting surgeon reports he is a first time user to the 3dmax mesh and was unsure whether the issue was technique or mesh related.The adverse reactions section of instructions-for-use, supplied with the device, lists migration and hernia recurrence as possible complications.The warning section states, "to prevent recurrences when repairing hernias, the mesh should be sized with appropriate overlap for the size and location of the defect, taking into consideration any additional clinical factors applicable to the patient.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue." a review of manufacturing records was performed and found that the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1,452 units released for distribution.Note, the date of event (11-jul-2025) is considered to be the best estimate based on the date of awareness.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: 22614720
• Report Number: 1213643-2025-00689
• Device Sequence Number: 15854031
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(11)240905(17)290828(10)HUJV0865
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: 0115320
• Device Lot Number: HUJV0865
• 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: 07/11/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2024
• 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 Age: 80 YR
• Patient Sex: Male