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

Catalog Number	0115311
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2022- patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax meshes (device 1 and 2).Per op notes, "a large indirect hernia sac was identified in right inguinal region and dissected.A 3dmax mesh (device 1) was then placed and sutured.There was a direct hernia and an indirect sac in the left inguinal region and was dissected.A 3dmax mesh (device 2) was then placed and sutured." on (b)(6) 2022- patient was diagnosed with infected mesh bilateral groins, thereby underwent laparoscopic repair with explant of 3dmax meshes (device 1 and 2).Per op notes, "in the left inguinal region, adhesions from the anterior abdominal wall was identified and the 3dmax mesh (device 2) was found free floating and was excised.In right inguinal region, most part of 3dmax mesh (device 2) was found to be inflamed and infected.Abscess through rectus muscle was also noted and the 3dmax mesh (device 1) was completely excised.".
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-2022) is considered to be a best estimate.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: 50083001
• Report Number: 1213643-2026-00979
• Device Sequence Number: 10253603
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)270328(10)HUGQ2104
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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 Catalogue Number: 0115311
• Device Lot Number: HUGQ2104
• 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: 07/14/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2022
• 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 Sex: Male