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 Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	11/11/2015
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-may-2013) is considered to be a best estimate.This emdr represents the bard/davol 3dmax (device 2).An additional supplemental emdr was submitted to represent the bard/davol 3dmax (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: on (b)(6) 2014 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of two 3dmax mesh (device 1 and 2).Per op notes, "an incision was made in the right lower quadrant, a 3dmax mesh (device 1) was placed into the defect using prolene sutures.A second piece of 3dmax mesh (device 2) was placed to the midline using tacks." on (b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia thereby underwent repair.Per op notes, "an incision was made through an old scar in the right lower quadrant and carried down.Encountered the old mesh (device 1 and 2), which was adherent to the floor all the way down to the symphysis pubis.A synthetic mesh was placed.".

• 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: 23953907
• Report Number: 1213643-2026-00002
• Device Sequence Number: 18779118
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758(17)180528(10)HUXE0749
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2026

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: 05/28/2018
• Device Catalogue Number: 0115320
• Device Lot Number: HUXE0749
• 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: 01/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2013
• 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: 49 YR
• Patient Sex: Male