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	08/10/2017
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-2014) is considered to be a best estimate.This mdr represents the 3dmax light (device 1).An additional supplemental emdr was submitted to represent the perfix plug (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) 2015 - patient was diagnosed with symptomatic left inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax light (device 1).Per op notes, ¿an inferior umbilical incision was made.An indirect incarcerated hernia sac was identified and reduced.A 3dmax light (device 1) was placed in the pre-peritoneal space and tacked to cooper¿s ligament.¿ (b)(6) 2016 - patient was diagnosed with lipoma and small left inguinal hernia thereby underwent open repair with implant of perfix plug (device 2).Per op notes, ¿a left inguinal incision was made.A small weakness in the medial floor of the inguinal canal was identified.A perfix plug (device 2) was placed into the floor and fascia closed over it.¿ (b)(6) 2017 ¿ patient was diagnosed with recurrent left inguinal hernia thereby underwent robotic assisted repair with implant of 3dmax mesh (device 3).Per op notes, ¿adhesions to the bilateral inguinal areas were identified and taken down.The mesh (device 1) along the posterior area was dissected away from the inferior epigastric vessels which were completely adhered to it.A very large direct hernia was identified and reduced.The mesh (device 2) that was placed along the anterior surface of the area was noted and it was left alone.A 3dmax mesh (device 3) was placed and secured to the pubic tubercle with sutures.¿.

• 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: 24505065
• Report Number: 1213643-2026-00284
• Device Sequence Number: 9943519
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(17)190428(10)HUYC1441
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 02/26/2026

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: 04/28/2019
• Device Catalogue Number: 0117311
• Device Lot Number: HUYC1441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2014
• 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: 58 YR
• Patient Sex: Male