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

Catalog Number	0115320
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/03/2021
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-feb-2017) is considered to be a best estimate.This emdr represents the bard 3dmax mesh (device 2).Additional supplemental emdrs was submitted to represent the 3dmax mesh (device 1) and bard flat mesh (device 3).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) 2018 - patient was diagnosed with bilateral recurrent inguinal hernias and umbilical hernia thereby underwent robotic repair with the implant of 3dmax meshes (left - device 1, right ¿ device 2).Per op notes, "bilateral hernia was noted.A medium 3dmax meshes (device 1, 2) was placed bilaterally and secured to fascia using sutures to cover all the defects.The umbilical hernia was repaired using sutures." (b)(6) 2021 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with the implant of two bard flat meshes (device 3, 4).Per op notes, "on right inguinal canal, a direct inguinal hernia was noted.Previous mesh (device 2) was palpable along the inguinal floor.A bard flat mesh (device 3) was trimmed to size with a slit cut in keyhole fashion and positioned over the hernia defect using suture to the pubic tubercle inferiorly and shelving edge of the inguinal ligament.On left side, small direct inguinal hernia was noted.A bard flat mesh (device 4) was also used for the left inguinal hernia and secured using sutures.".

• 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: 25034187
• Report Number: 1213643-2026-00577
• Device Sequence Number: 9039511
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)220228(10)HUBP2343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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 Expiration Date: 02/28/2022
• Device Catalogue Number: 0115320
• Device Lot Number: HUBP2343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2017
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 82 KG