3DMax

Description of Event or Problem

Per information provided:(b)(6)2019 - Patient was diagnosed with recurrent left indirect inguinal hernia, right indirect inguinal hernia, umbilical hernia thereby underwent laparoscopic repair with the implant of 3DMax Meshes (Device 1, 2). Per op notes, "On right, hernia was noted and recurrent left sided hernia was found. An indirect sac was reduced. A right and left sided 3DMax Meshes (Device 1, 2) were placed into defect to cover the direct, indirect spaces on each side using tacks. The umbilical hernia was repaired using sutures."Attorney alleges Pain.

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. Note, the date of event (21-Jul-2026) is considered to be the best estimate based on the date of awareness.This eMDR represents the 3DMax Mesh (Device 2). An additional supplemental eMDR was submitted to represent the 3DMax Mesh (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.