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

Catalog Number	0116322
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including hernia recurrence, scar tissue, pain and explant post implant of 3dmax mid.The instructions-for-use supplied with the device lists hernia recurrence and pain as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the date of manufacturer (15-mar-2022) is considered to be a best estimate.This mdr represents the 3dmax mid (device #1).An additional mdr was submitted to represent the bard flat mesh (device #2).Should additional information be provided, a supplemental emdr will be submitted.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
Attorney alleges that the patient was implanted with 3dmax mid mesh (device #1) (cat# 0116322; lot# hugqab10) during an inguinal hernia repair surgery on (b)(6) 2022.It was alleged that the patient had recurrent right inguinal hernia and thereby underwent repair with the implant of bard flat mesh (device #2) (cat# 0112680; lot# hufy0486) on (b)(6) 2023, during the procedure the surgeon noted that the "scarring around the hernia sac and the cord structures".It was also alleged that patient experienced hernia recurrence, chronic pain and additional surgical intervention which have impaired daily activities post implant of both meshes.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the device was defective.This file represents 3dmax mid (device #1).

• Brand Name: 3DMAX MID
• 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: 21571388
• Report Number: 1213643-2025-00085
• Device Sequence Number: 8647605
• Product Code: FTL
• UDI-Device Identifier: 00801741200793
• UDI-Public: (01)00801741200793(17)270228(10)HUGQAB10
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2025

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: 0116322
• Device Lot Number: HUGQAB10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/11/2025
• 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