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

Catalog Number	0115311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hernia (2240); Ambulation or Postural Difficulties (2544); Weight Changes (2607); Unspecified Gastrointestinal Problem (4491); Pelvic Pain (4865)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As alleged, patient experienced post operative complications following the implantation of 3dmax mesh, including intense pain in lower pelvis and recurrence of hernia.Based on the information provided, no conclusions can be made.The degree to which the 3dmax mesh implant used to treat the patient, may be causing, or contributing to the ongoing symptoms is unknown.A review of manufacturing records was conducted and shows the product was manufactured according to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Pain and hernia recurrence are listed as possible complications in the adverse reactions section of the instructions-for-use, provided with the device.This mdr represents 3dmax mesh left (device #1).Additional mdr was submitted to represent the 3dmax mesh right (device #2).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 per ansm report: (b)(4).Summary of reported event: (b)(6) 2025 ¿ patient had bilateral inguinal hernias thereby underwent laparoscopic repair with the implant of two bard 3dmax mesh (device 1, 2).Per op notes, ¿bilateral direct inguinal hernia was revealed.The anterior parietal peritoneum above the hernial sac was dissected.A 10.8x16cm bard prosthesis (device 1) on the left and an 8.5x13.7cm prosthesis (device 2) on the right were placed and closed using sutures.¿ (b)(6) 2025 ¿patient experienced pain in lower pelvis which radiated to the testicles, inner thigh and anus.An ultrasound and pelvic ct scan confirmed the recurrence of both inguinal hernias, as well as the appearance of a small umbilical hernia.(b)(6) 2025 ¿ patient had debilitating pain and was diagnosed with bilateral pre-hernial lipoma thereby underwent open repair.Per op notes, ¿on left side, the spermatic cord is identified and ligated.Dissection of the pre-hernial lipoma confirmed the presence of an indirect hernia with fatty content.The hernia was resected.The parietal substance loss was repaired by placing an unknown prothesis which fixed to pubic spine, crural arch, tendon joint using sutures.On right, the same procedure was performed and an indirect pre hernial lipoma was found.¿ (b)(6) 2025 ¿ per doctor's notes: current condition of the patient: functional disability (pain when walking, difficulty carrying light loads, difficulty performing daily tasks) digestive and transit problems, weight loss psychological impact of disability daily intake of morphine-based painkillers and paracetamol since the first operation (8 months).Patient has a scheduled appointment at the pain clinic for (b)(6) 2026.

• 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: 24052706
• Report Number: 1213643-2025-01339
• Device Sequence Number: 13127918
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(11)240726(17)290628(10)HUJU1529
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0115311
• Device Lot Number: HUJU1529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 59 KG