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

Catalog Number	0117320
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695)
Date of Event	01/15/2019
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-2016) is considered to be a best estimate.This emdr was submitted to represent the bard/davol 3dmax light mesh (device #3).Additional supplemental emdr's was submitted to represent the bard/davol mesh ¿ perfix plug (device #1, #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) 2012 ¿ patient was diagnosed with umbilical hernia and right inguinal hernia thereby underwent open repair with the implant of two perfix plug (device #1, #2).Per op notes, ¿there was a large direct defect.Two extra-large perfix plugs (device #1, #2) were placed in the defect and patch was tacked to the pubic tubercle medially, inferiorly to shelving edge of inguinal ligament and superiorly to conjoined tendon using sutures.The umbilical hernia was repaired using sutures.¿ (b)(6) 2016 ¿ patient was diagnosed with right recurrent indirect inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax light mesh (device #3).Per op notes, ¿some mesh plugs (device #1, #2) were adherent.The hernia was lateral so there was an indirect inguinal hernia.Then, a 3dmax light mesh (device #3) was tacked on either side of epigastric as well as medially to the cooper¿s ligament.¿ (b)(6) 2019 ¿ patient was diagnosed with right lower quadrant abdominal pain thereby underwent laparoscopic lysis of adhesions.Per op notes, ¿in the right groin, adhesions of the right colon and cecum to the previously placed preperitoneal mesh (device #3), and medial protrusion of a corner of the mesh consistent with a plug and patch (device #1, #2) repair.Adhesiolysis were performed.¿.

• 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: 22201872
• Report Number: 1213643-2025-00484
• Device Sequence Number: 18071098
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052(17)210128(10)HUAP0130
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• 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): 06/09/2025

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: 01/28/2021
• Device Catalogue Number: 0117320
• Device Lot Number: HUAP0130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2016
• 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: 56 YR
• Patient Sex: Male