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	Nerve Damage (1979); Pain (1994); Hernia (2240)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient has experienced chronic pain, nerve entrapment and recurrence of hernia post implant of 3dmax mesh.Based on the information provided the degree to which the 3dmax mesh used to treat the patient, may have caused or contributed to the patient's postoperative course is unknown.Hernia recurrence and pain are identified in the adverse reaction section of the instructions-for-use (ifu), included with the product as possible complications.The warning section of the ifu states, "to avoid injury, careful attention is required if fixating the mesh in the presence of nerves, vessels, or the spermatic cord.Fastener penetration into underlying tissue containing nerves or blood vessels may result in the need for medical/surgical intervention, cause serious injury or permanent impairment to a body structure." review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) 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.
Event or Problem Description
As reported, patient underwent keyhole hernia (left inguinal) repair using a 3dmax mesh on (b)(6) 2024.Post surgery patient has experienced chronic pain, nerve entrapment and recurrence of the hernia.The condition is treated by otc medication for pain management.Patient had a consultation for neurectomy but has decided against this procedure for now.Current condition of the patient is stable and will have revision surgery to repair the hernia.

• 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: 23630232
• Report Number: 1213643-2025-01117
• Device Sequence Number: 10380805
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(11)240115(17)281228(10)HUJN0522
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/31/2025

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: HUJN0522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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: Disability; Other
• Patient Sex: Male