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

Catalog Number	0117321
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Hernia (2240)
Date of Event	09/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2015 - patient was diagnosed with bilateral direct inguinal hernias thereby underwent open repair with implant of 3dmax light mesh (device 1 - left and device 2 - right).Per operative notes, "an incision was made into the left inguinal region.The hernia sac was dissected out.A 3dmax light mesh (device 1) was placed into the left inguinal floor and secured it with sutures.Another incision was made into the right groin.The hernia sac was dissected out.A 3dmax light mesh (device 2) was placed into the right inguinal region and secured it with sutures." attorney alleges that patients had hernia recurrence, nerve damage, mesh shrinkage and pain.
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-2014) and date of event (15-sep-2026) are considered to be a best estimate.This emdr 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.

• 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: 50837738
• Report Number: 1213643-2026-01214
• Device Sequence Number: 10263188
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(17)190928(10)HUYI1432
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/17/2026

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: 09/28/2019
• Device Catalogue Number: 0117321
• Device Lot Number: HUYI1432
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2014
• 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: Disability
• Patient Sex: Male