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

Catalog Number	0115320
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-apr-2016) is considered to be a best estimate.This mdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the 3dmax mesh (device 1).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
Per information provided: (b)(6) 2016 ¿ patient was diagnosed with right inguinal hernia thereby underwent robotic assisted repair with implant of 3dmax mesh (device 1 and device 2).Per operative notes, ¿the hernia sac was identified and dissected.A large 3dmax mesh (device 1 and device 2) were placed into the abdomen, and this was aligned over the hernia space to cover both the direct, the indirect and femoral spaces with overlap onto cooper¿s ligament and tacked.¿ (b)(6) 2020 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent robotic ¿ assisted laparoscopic repair with implant of 3dmax mesh (device 3).Per operative notes, ¿a right sided 3dmax mesh (device 1 and device 2) that appeared to have folds laterally and inferiorly.It was an early recurrence with a small hernia defect but certainly not in appropriate position.It was folded and malpositioned.A large 3dmax mesh (device 3) was placed into the hernia space with good medial coverage of cooper¿s ligament and the femoral canal.The mesh was tucked in front of the old mesh and positioned so the bottom half of the new mesh and old mesh would overlap and sewed the two pieces of mesh together.¿.

• 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: 23836364
• Report Number: 1213643-2025-01241
• Device Sequence Number: 9030817
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)210428(10)HUAR2441
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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 Expiration Date: 04/28/2021
• Device Catalogue Number: 0115320
• Device Lot Number: HUAR2441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2016
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 72 KG