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

Catalog Number	0115311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Nerve Damage (1979); Neuropathy (1983); Pain (1994); Anxiety (2328)
Date of Event	09/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, on (b)(6) 2018 the patient was implanted with a 3dmax mesh for what was thought to be an inguino-scrotal hernia per ultrasound images.Reportedly, during the implant procedure, the surgeons reportedly found no hernia, but a prosthetic patch was fitted nonetheless.Subsequent review of the ultrasound images actually corresponded to a varicocele, which is still present today.As reported since implant the patient reports " i currently experience chronic daily pain, significant functional impairment documented neurological damage, psychological impact with reactive anxiety, persistence of the mass initially suspected prior to the operation." no additional information can be requested.Based on the information reported, no conclusions can be made as to the degree to which the implant may have caused or contributed to the patient¿s postoperative course.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain as a possible complication.A review of manufacturing records was performed and found the device was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4).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
As per ansm n° r2615162 (in summary): it was reported that the patient underwent left inguinal scrotal hernia repair with the implant of 3dmax mesh on (b)(6) 2018.Initially, a varicocele was suspected due to a palpable mass in the left testicle.During the first urology consultation, no clinical diagnosis of a hernia had been made.However, a subsequent ultrasound scan revealed an image interpreted as an inguino-scrotal hernia, without any further clinical examination.On the basis of this radiological finding alone, the initial hypothesis of a varicocele was abandoned and surgery was scheduled promptly.During the operation, the surgeons reportedly found no hernia, but a prosthetic patch (3dmax mesh) was fitted nonetheless.Since this operation, the patient is suffering from chronic, debilitating neuropathic pain in the groin and left leg, with neurological impairment confirmed by various medical examinations.Subsequently, several specialist doctors and experts consulted questioned the initial diagnosis of a hernia and concluded that the ultrasound images actually corresponded to a varicocele, which is still present today.The mass initially suspected is, moreover, still present despite the operation.Current condition of the patient: since the surgical procedure on (b)(6) 2018, the patient is experiencing chronic and debilitating neuropathic pain in the left groin, radiating down to the left lower limb.Several tests and specialist opinions have revealed nerve damage linked to the prosthetic plate inserted during the operation.The pain persists despite various pain-relieving treatments, injections and specialist follow-up.The patient currently experience chronic daily pain, significant functional impairment documented neurological damage, psychological impact with reactive anxiety, persistence of the mass initially suspected prior to the operation.The patient's condition has necessitated prolonged follow-up with several specialists (pain management, neurology, psychiatry) as well as a judicial assessment procedure currently underway.Actions undertaken at the healthcare facility for the patient's care: nr.

• 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: 25453153
• Report Number: 1213643-2026-00738
• Device Sequence Number: 16054782
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734(17)230428(10)HUCQ1497
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

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 Expiration Date: 04/28/2023
• Device Catalogue Number: 0115311
• Device Lot Number: HUCQ1497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2018
• 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: Other
• Patient Sex: Male