MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 3DMax Light; Surgical Mesh

Catalog Number	0117311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/17/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with bilateral inguinal hernias and an umbilical hernia thereby underwent laparoscopic repair of bilateral inguinal hernias with the implant of two 3dmax light meshes (device 1 - right and 2 - left) and open umbilical hernia repair with the implant of ventralex st hernia patch (device 3).Per op notes, "two 3dmax light meshes (device 1 - right and 2 - left) were placed bilaterally using tacks.Next, the umbilical defect was identified.A small ventralex st hernia patch (device 3) was placed in the peritoneal cavity using prolene sutures." (b)(6) 2014 - patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent robotic-assisted laparoscopic repair of recurrent right inguinal hernia with the removal of mesh (device 1) and implant of perfix plug (device 4), open repair of left inguinal hernia with the implant of perfix plug (device 5).Per op notes, "omental adhesions were taken down on both left and right mid abdomen.Explored on the right side, the mesh (device 1) was dissected off the anterior abdominal wall.Then a medium perfix plug (device 4) was placed into the abdominal cavity.Attention was then turned towards the left inguinal area; there is herniated fat anterolaterally consistent with a "lipoma of the cord¿.Another medium perfix plug (device 5) was placed to the internal ring." this file represents 3dmax light (device 2).
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-sep-2011) is considered to be a best estimate.This emdr represents the 3dmax light (device 2).An additional emdr and supplemental emdr were submitted to represent the 3dmax light (device 1) and ventralex st hernia patch (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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50050311
• Report Number: 1213643-2026-00948
• Device Sequence Number: 13166073
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(17)161028(10)HUVI2070
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

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: 10/28/2016
• Device Catalogue Number: 0117311
• Device Lot Number: HUVI2070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2011
• 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 Sex: Male
• Patient Weight: 209 LB