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

Catalog Number	0117311
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As per ansm (n° r2606566): (b)(6) 2025 patient was implanted with a 3dmax light mesh.Date of occurrence: (b)(6) 2026.Description of incident: laparoscopic repair of left inguinal hernia.As per the surgical report of (b)(6) 2025: diagnosis: symptomatic left inguinal hernia nature of the procedure: radical repair under laparoscopy with placement of a prosthesis via the preperitoneal route under general anesthesia.Supine position.Orotracheal intubation.Laparoscopy position.Betadine antiseptic.Surgical drapes in place.Complete preoperative checklist.Injection of 2 g cefazolin at induction.Incision below the umbilicus.Opening of the rectus sheath and creation of a prevesical space with a balloon.Insufflation at 12 cm of mercury after placement of a 10 mm trocar.Exploration confirms the presence of an indirect hernia.A 5 mm trocar was placed on the midline.Using bipolar forceps, the bladder was freed behind the pubis, then the peritoneum was freed in the left iliac fossa.A second 5 mm trocar was placed under visual control.Using the two dissecting forceps, we can release the indirect hernia sac by pediculating the vas deferens and spermatic vessels.The hernia is completely reduced.Then, a 15 x 11 left bard 3d light mesh anatomical prosthesis is inserted.This plate is placed in front of the inguinal orifice, resting behind the pubis and laterally beyond the psoas.Complete hemostasis and exsufflation under visual control, ensuring the correct positioning of the prosthesis.Removal of the trocars.Umbilical closure with vicryl 0 x-stitch and skin closure with vicryl 3/0 fast-absorbing sutures and strips.Analgesia with naropine 7.5 20cc at trocar sites.Current patient status: chronic pain in the left groin.Actions taken in the healthcare facility for the patient's care: nr.
Additional Manufacturer Narrative
As reported, patient had experienced chronic pain in the left groin post implant of 3dmax light mesh.No additional information can be requested.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 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 that the device was manufactured to specification.To date, this is the only reported complaint for this lot of 1,481 units released for distribution.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 LIGHT
• 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: 24637504
• Report Number: 1213643-2026-00344
• Device Sequence Number: 9797504
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038(11)250108(17)291228(10)HUJZ0962
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 0117311
• Device Lot Number: HUJZ0962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2025
• 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