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	Adhesion(s) (1695); Hernia (2240)
Date of Event	11/16/2017
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-mar-2016) is considered to be a best estimate.This mdr represents the 3dmax mesh (device 1).An additional supplemental emdr was submitted to represent the 3dmax mesh (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.
Event or Problem Description
Per information provided: (b)(6) 2016 ¿ patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of two 3dmax meshes (device 1 and 2).Per operative notes, ¿in the left preperitoneal inguinal space, an indirect inguinal hernia with sac was reduced.A large size 3dmax mesh (device 1) was placed on hernia defect wall and secured with sutures.In the right preperitoneal inguinal space, an indirect inguinal hernia with sac was reduced.A medium size, 3dmax mesh (device 2) was placed into the position to cover the hernia defect.¿ (b)(6) 2017 - patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device 3).Per operative notes, ¿extensive adhesions and small recurrent right inguinal hernia was noted and reduced.A medium size, 3dmax mesh (device 3) was placed covering recurrent hernia defect.The mesh (device 2) was replaced in prior position which slightly overlapped new mesh (device 3).In the left side, extensive adhesions of prior mesh (device 1) to anterior abdominal wall was reduced.The hernia content contained half of prior placed mesh (device 1).The mesh (device 1) was readjusted and left in place.¿.

• 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: 23941203
• Report Number: 1213643-2025-01293
• Device Sequence Number: 20800562
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)210328(10)HUAQ1142
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/31/2025

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 Expiration Date: 03/28/2021
• Device Catalogue Number: 0115311
• Device Lot Number: HUAQ1142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2016
• 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: 42 YR
• Patient Sex: Male