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

Catalog Number	0115320
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Inflammation (1932); Nerve Damage (1979); Pain (1994)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2020 - patient was diagnosed with bilateral inguinal hernia thereby underwent robotic assisted repair with implant of 3dmax mesh (device 1 and 2).Per op notes, "an incision was made.Omental adhesions were taken down.Left peritoneum was taken down and identified both the indirect and direct defect which were reduced from the spermatic cord.A large piece of 3dmax mesh (device 1) was placed and the peritoneum was secured with suture.On the right side, the peritoneum was taken down in a similar fashion and a defect was noted in a direct position.A medium piece of 3dmax mesh (device 2) was placed and secured the peritoneum with suture." on (b)(6) 2020 - patient was diagnosed with adhesions to the site of bilateral inguinal hernia thereby underwent robotic assisted repair with partial excision of 3dmax mesh (device 2).Per op notes, "old incision site was used.Extensive adhesions between the omentum and bowel to both inguinal hernia repair sites were noted.Adhesions were taken down.Well incorporated mesh was noted in the left inguinal repair site.The right side had an area of wrinkles in its lateral portion and these were attached to the adhesions.All adhesions were stripped of the right inguinal area and the wrinkle portion of the mesh was explanted." on (b)(6) 2021 - patient was diagnosed with bilateral chronic groin pain thereby underwent laparoscopic repair with excision of 3dmax mesh (device 1 and 2).
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.This emdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the 3dmax 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
• 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: 50584841
• Report Number: 1213643-2026-01149
• Device Sequence Number: 10351817
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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 Catalogue Number: 0115320
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male