MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT; Mesh, surgical, polymeric

Catalog Number	0117321
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Nerve Damage (1979); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	02/06/2026
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-jun-2017) is considered to be a best estimate.This mdr represents the 3dmax light (device 2).An additional supplemental emdr was submitted to represent the 3dmax light (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: (b)(6) 2017 - patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax light (device 1 and 2).Per op notes, ¿a curvilinear skin incision was made.A direct pseudo sac was identified on the right and dissected away.A 3dmax light (device 2) was placed on the direct defect and secured to the anterior abdominal wall with tacking device.The direct hernia was identified on the left.A 3dmax light (device 1) was placed and secured to the anterior abdominal wall with tacking device.Two pieces of mesh had a small degree of overlap in the midline.¿.

• Brand Name: 3DMAX LIGHT
• Common Device Name: Mesh, surgical, polymeric
• 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: 24469432
• Report Number: 1213643-2026-00251
• Device Sequence Number: 10262193
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(17)220628(10)HUBT1706
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 06/28/2022
• Device Catalogue Number: 0117321
• Device Lot Number: HUBT1706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2017
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male