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

Catalog Number	0115310
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2005 - patient was diagnosed with bilateral inguinal hernia- right direct , left indirect hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device #1- right and device #2- left).Per operative notes, ¿in right side, the perineum over the indirect ring was incised and dissected away from internal ring and cord structures.A medium size bard 3d mesh (device #1- right) was placed over the cooper¿s ligament covering the indirect defect and area of the internal ring and tacked.In left side, the indirect sac was reduced, peritoneum was further dissected and placed with medium size bard 3d mesh (device #2- left) over the cooper¿s ligament covering both the defect as well as the indirect defect." on (b)(6) 2018 - patient was diagnosed with recurrent left inguinal hernia and right groin pain thereby underwent open repair with neurolysis.Per operative notes, ¿the mesh caused bulging through the floor of the inguinal canal in left side.The mesh was also noted to not be attached to anything at the inferior aspect, and a tack could be seen protruding.The metallic corkscrew tack was removed.The hernia was primilarly repaired using sutures.In right groin, neurolysis of ilioinguinal nerve and genitofemoral nerve was performed and sutured.".
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 (device #2); additional supplemental emdr was submitted to represent the 3dmax (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.; 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 ; 4018258495
• MDR Report Key: 21949458
• Report Number: 1213643-2025-090188
• Device Sequence Number: 12970847
• Product Code: FTL
• UDI-Device Identifier: 00801741030727
• UDI-Public: (01)00801741030727(10)43KOD306
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 0115310
• Device Lot Number: 43KOD306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Sex: Male