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

Catalog Number	0117311
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Nerve Damage (1979); Hernia (2240)
Date of Event	06/05/2019
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-oct-2017) is considered to be a best estimate.This mdr represents the 3dmax light mesh (device 2).An additional supplemental emdr was submitted to represent the 3dmax light mesh (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) 2018: patient was diagnosed with bilateral inguinal hernia and umbilical hernia thereby underwent robotic repair with the implant of 3dmax light meshes (right ¿ device 1, left ¿ device 2).Per op notes, ¿a palpable umbilical hernia was identified.On right, a large direct inguinal hernia was identified.A large 3dmax light mesh (device 1) was placed and secured laterally using sutures.On left side, direct inguinal hernia was noted.A another 3dmax light mesh (device 2) was placed and secured medially in same fashion using sutures.¿ on (b)(6) 2019: patient was diagnosed with recurrent bilateral inguinal hernia and umbilical hernia thereby underwent open repair with the implant of synthetic meshes.Per op notes, ¿the mesh (device 1, 2) had been rotated superiorly and patient had bilateral recurrent inguinal hernias.The mesh was well incorporated.On right, the ilioinguinal nerve was resected.A large direct hernia was identified.A synthetic mesh was placed into internal ring using sutures.On left, the nerve was resected.A small direct inguinal hernia was repaired with synthetic mesh using sutures.The small umbilical hernia was dissected out.¿.

• 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: 24207161
• Report Number: 1213643-2026-00048
• Device Sequence Number: 21250689
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(17)221128(10)HUBX1018
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2026

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: 11/28/2022
• Device Catalogue Number: 0117311
• Device Lot Number: HUBX1018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2017
• 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: Disability; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 78 KG