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

Catalog Number	0115321
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	11/22/2019
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.This mdr represents the 3dmax mesh (device 2).An additional supplemental emdr was submitted to represent the perfix plug (device 1) and an additional mdr was submitted to represent bard flat mesh (device 3).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) 2016- patient was diagnosed with symptomatic recurrent right inguinal hernia, thereby underwent open repair with implant of perfix plug (device 1).Per op notes, ¿the hernia defect was identified in the floor of the right inguinal region.A perfix plug (device 1) was placed into the defect and sutured¿.On (b)(6) 2017- patient was diagnosed with right recurrent inguinal hernia, thereby underwent laparoscopic repair with implant of 3dmax mesh (device 2), bard flat mesh (device 3) and a synthetic mesh.Per op notes, ¿hernia was noticed on right and left side of the inguinal region.On the right side there was a large direct inguinal hernia.A large 3dmax mesh (device 2) was trimmed and placed in the right inguinal region and the synthetic mesh was placed over the 3dmax mesh (device 2) and tacked.Again, a large bard flat mesh (device 3) was placed customized, placed and tacked to cooper¿s ligament across the top of fascia.¿.On (b)(6) 2019- patient was diagnosed with right recurrent inguinal hernia with pain, thereby underwent robotic assisted laparoscopic repair with implant of synthetic mesh.Per op notes, ¿a recurrent direct defect on the right side was noted.The hernia contents were reduced.A synthetic mesh was placed into the defect and sutured.¿.

• 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 ; 8005566756
• MDR Report Key: 23896822
• Report Number: 1213643-2025-01273
• Device Sequence Number: 20166391
• Product Code: FTL
• UDI-Device Identifier: 00801741030765
• UDI-Public: (01)00801741030765
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• 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): 12/24/2025

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: 0115321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/26/2025
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male