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

Catalog Number	0117321
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2015 - patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax light mesh (device 1).Per op notes, "a periumbilical incision was made and was carried down, a large 3dmax light mesh (device 1) was placed into the right side of the inguinal area and to the cooper's ligament." (b)(6) 2016 - patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with the implant of bard mesh pre-shaped w/ keyhole (device 2).Per op notes, "the 3dmax light mesh (device 1) was palpated.A bard mesh pre-shaped w/ keyhole (device 2) was placed to the pubic tubercle using prolene sutures." (b)(6) 2017 - patient was diagnosed with recurrent right inguinal hernia thereby underwent laparoscopic repair with the implant of bard flat mesh (device 3).Per op notes, "there was a right-sided recurrence of hernia and could see the old mesh (device 1 and 2) in the preperitoneal position.Identified the old mesh had curled up and allowed the edge of the peritoneum.A bard flat mesh (device 3) was placed.".
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-dec-2014) is considered to be a best estimate.This mdr represents the 3dmax light mesh (device 1).An additional supplemental emdr was submitted to represent the bard mesh pre-shaped w/ keyhole (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.

• Brand Name: 3DMAX LIGHT
• 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: 24481540
• Report Number: 1213643-2026-00259
• Device Sequence Number: 10125935
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(17)191228(10)HUYL0165
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2026

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: 12/28/2019
• Device Catalogue Number: 0117321
• Device Lot Number: HUYL0165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2014
• 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: 52 YR
• Patient Sex: Male