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

Catalog Number	0115310
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Dysuria (2684)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per ansm user report (b)(4): description of the incident: period since occurrence since the implantation ((b)(4) 2024) of two (2) prostheses (3dmax mesh left and right) as part of treatment for bilateral inguinal hernias, i have experienced occasional acute pain (urinary and/or spermatic function) and milder recurring pain on a daily basis.Actions taken by the healthcare facility to treat the patient: nr this file represents 3dmax mesh left.
Additional Manufacturer Narrative
As reported, patient experienced occasional acute pain (urinary and/or spermatic function) and milder recurring pain on a daily basis since the implant of two 3dmax mesh (left and right).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 complication.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This mdr represents the 3dmax mesh left (device 1).An 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.

• 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: 24413079
• Report Number: 1213643-2026-00197
• Device Sequence Number: 18793711
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727
• 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): 02/10/2026

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: 0115310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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