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

Catalog Number	0115320
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Depression (2361)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per ansm report (no, (b)(4)) in summary: as reported, the patient underwent right inguinal hernia repair on (b)(6) 2019 and was implanted with a 3dmax right mesh.As reported, the patient underwent left inguinal hernia repair on (b)(6) 2019 and was implanted with a 3dmax left mesh.Date of occurrence: (b)(6) 2019.Description of the incident: "following severe, debilitating pain, the surgeon told me that everything was fine, the plates were in place, and that i should see a gynaecologist specializing in endometriosis given my symptoms.He did not want to investigate further, as the pain was normal in his opinion.I underwent numerous inconclusive, very painful, humiliating and unanswered tests (pelvic mri, pelvic endo ultrasound, brain mri, spinal cord mri, electromyogram, etc.) and various treatments (very heavy, up to 34 medications and a stay in a psychiatric hospital).I saw many specialists in angers, tours and le mans.Superficial endometriosis, fibromyalgia, bladder problems (neurostimulator implanted), irritable bowel syndrome (sibo), and severe depression are my conditions, but i will spare you the details." (b)(6) 2026 - my surgeon, removed 4/5 of the prosthesis on the right side.He couldn't remove it all because otherwise he would have made a hole in my bladder.The operation took much longer than expected because there were adhesions everywhere.I will probably have to have the left side done.I have been physically and mentally 'rubbish' since my first operation, which has hidden more than six years of my life.I have been treated like a nobody and made to feel like i am crazy.I no longer have a professional or social life because of all the problems that the prostheses have caused me.I cannot write about everything i have been through, achieved, paid for, because the financial aspect is also catastrophic.Clinical consequences and current status: "professional life: on leave since (b)(6) 2024 - short periods of leave before that - i cannot do anything like everyone else, i need adjustments to my work, my working hours." personal life: i can't go out like other young women my age - i get tired very quickly - every outing has to be organised according to how i feel - i have a pill box like an elderly person - i'm on very strong medication, my treatments change, i go through withdrawal too often - my pain dictates my life and that of my family too - my body has not been mine for a long time - depression and much more - every time new problems arise - i would not wish anyone to live in my body or have my life.Pain is considered normal for me, i don't know what it's like to be 'normal' without problems, without all the context that goes with it.I would need an entire book to explain, recount and prove my words." actions taken in the healthcare facility for the management of the patient: nr.This file represents the 3dmax right mesh.
Additional Manufacturer Narrative
As alleged, the patient experienced postoperative pain, adhesions and depression post implant of 3dmax right mesh.As alleged the patient subsequently underwent a procedure to explant the right sided mesh during this procedure adhesions were noted.Based on the information available, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient's postoperative complications.The adverse reactions section of the instructions-for-use supplied with the device lists pain and adhesion as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the 3dmax right mesh (device 1).An additional emdr was submitted to represent the 3dmax left mesh (device 2).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 ; 8005566756
• MDR Report Key: 24620820
• Report Number: 1213643-2026-00343
• Device Sequence Number: 10198956
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/17/2026
• 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: Required Intervention
• Patient Sex: Female