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	Urinary Tract Infection (2120); Depression (2361); Numbness (2415); Neuralgia (4413); Thrombosis/Thrombus (4440)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per ansm (no.(b)(4)): as reported, on (b)(6) 2024 the patient underwent a bilateral laparoscopic inguinal hernia repair procedure with the implant of two 3dmax mesh (left and right).The mesh devices were secured with a non-bd/bard fixation system.Date of occurrence: (b)(6) 2024.Description of the incident: "severe pain in right testicle, superficial thrombosis of the penis, loss of sensation in left thigh since surgery." the immediate postoperative period was uneventful, with a return to a normal diet that was well tolerated, in accordance with the enhanced recovery after surgery protocol.Given the favorable outcome, he was authorized to return home the same day.Occurrence of an adverse event during the stay: no.Current patient status: neuropathic pain chronic testicular pain on the right side, unexplained chronic urinary tract infections, chronic balanitis leading to circumcision.Depression, continued pain on the right side, like cramps.Loss of sensation in the left thigh above the knee, on antidepressants since (b)(6) 2025.Actions taken in the healthcare facility for the patient's care: nr.This report represents 3dmax large left.
Additional Manufacturer Narrative
As reported, the patient has experienced adverse symptoms post implant of the 3dmax mesh devices.There has been no surgical intervention reported.Based on the information provided, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.This emdr represents the 3dmax large left.An additional emdr was submitted to represent the 3dmax large right.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: 24498055
• Report Number: 1213643-2026-00275
• Device Sequence Number: 21361005
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)280228(10)HUHQ0193
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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: HUHQ0193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2023
• 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: Male