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

Catalog Number	0116311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Seroma (2069); Neuralgia (4413)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced allergic reaction, neuralgia, and seroma post implant of 3dmax mid meshes (left device 1 and right device 2).A mesh sample has been provided to the patient's allergist to perform reactivity testing.At this time, no conclusion can be made.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device list allergic reaction and seroma as possible complications.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.This mdr represents the 3dmax mid (device 1).An additional mdr was submitted to represent the 3dmax mid (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.
Event or Problem Description
As reported, on (b)(6) 2025, the patient underwent a bilateral inguinal hernia repair with implant of two 3dmax mid meshes (left device 1 and right device 2).It was reported that post implantation the patient experienced allergic reactions, post-operative pain began on (b)(6) 2025 and has persisted, including burning sensations at the surgical site, occasional testicular pain, and nerve pain in the leg.While some symptoms have improved, the patient continues to experience discomfort, especially at night.Bilateral groin pain was also reported on (b)(6) 2025.This file represents device 1.
Additional Manufacturer Narrative
As reported, the patient experienced allergic reaction, neuralgia, and seroma post implant of 3dmax mid meshes (left device 1 and right device 2).A mesh sample has been provided to the patient's allergist to perform reactivity testing.At this time, no conclusion can be made.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device list allergic reaction and seroma as possible complications.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.Addendum: this is an addendum to the previously submitted mdr to document reactivity test results.Reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.It is unknown at this time, what is causing the patient's condition.However, based on testing performed the postoperative symptoms experienced by the patient do not appear to be caused by the 3dmax mid mesh, used to treat the patient.Updated fields: b4, b5 (event description), b6 (relevant tests and lab data), g3, g6, h2, h6, h10.This supplemental mdr represents the 3dmax mid (device 1 / 1213643-2025-00886).An additional supplemental mdr was submitted to represent the 3dmax mid (device 2 / 1213643-2025-00915).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 reported, on (b)(6) 2025 the patient underwent a bilateral inguinal hernia repair with implant of two 3dmax mid meshes (left device 1 and right device 2).It was reported that post implantation the patient experienced allergic reactions, post-operative pain began on (b)(6) 2025 and has persisted, including burning sensations at the surgical site, occasional testicular pain, and nerve pain in the leg.While some symptoms have improved, the patient continues to experience discomfort, especially at night.Bilateral groin pain was also reported on (b)(6) 2025.Addendum: reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.This file represents 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: 23124958
• Report Number: 1213643-2025-00886
• Device Sequence Number: 13083241
• Product Code: FTL
• UDI-Device Identifier: 00801741200755
• UDI-Public: (01)00801741200755(11)241202(17)291128(10)HUJZ0005
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K200818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 0116311
• Device Lot Number: HUJZ0005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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 Age: 54 YR
• Patient Sex: Male